Medical Devices Safety Update, Volume 1, Number 1, November 2013
Medical Devices Safety Update is the medical device safety bulletin of the Therapeutic Goods Administration (TGA)
In this issue
- Riata and Riata ST silicone cardiac leads update
- Correct use of blood collection packs - spiking
- Frova intubating catheter/introducer
Cardiologists and other health professionals are advised that St Jude Medical has released updated data about certain models of Riata and Riata ST silicone cardiac leads, which are used with implantable cardiac cardioverter-defibrillators (ICDs).
St Jude Medical issued the initial safety alert regarding insulation problems with these leads in December 2010 and the TGA published a safety advisory on its website on 17 May 2012.
Since then, St Jude Medical has undertaken ongoing evaluation of the incidence of these problems and long-term performance of Riata and Riata ST silicone cardiac leads.
Initial findings from that evaluation were released in July 2012 and have recently been updated with information to the end of July 2013.
Importantly, the findings of the ongoing evaluation have not changed the information or patient management recommendations previously issued by St Jude Medical and published on the TGA website.
It was identified that the wires in Riata and Riata ST silicone cardiac leads could become exposed in two different ways:
- abrasion to the insulation surrounding the lead
- externalisation of the conductor
These issues could result in the ICD:
- delivering unnecessary additional electrical charges to the patient
- failing to operate when needed
- failing to provide effective therapy.
The supply of affected leads in Australia was discontinued in December 2010 and they were cancelled from the Australian Register of Therapeutic Goods.
There are several factors that could contribute to Riata and Riata ST silicone cardiac leads becoming exposed, including physiological stresses placed on the leads due to patient anatomy and implant orientation, and mechanical stresses caused by concomitant devices in the body.
It has been identified that the main causes of insulation problems are:
- lead-to-ICD abrasion
- lead-to-lead abrasion
- lead abrasion caused by structures in the heart or vasculature rubbing against the outside of the lead, resulting in exposure of the conductor
- pressure from the clavicle
- 'inside-out' abrasion caused by the movement of the cables within the insulation.
The TGA and St Jude Medical continue to monitor the safety and performance of Riata and Riata ST silicone cardiac leads.
A total of 3962 Riata and Riata ST silicone cardiac leads were supplied in Australia from 2003 until supply was discontinued in December 2010. To 30 April 2013, there were 128 reports (3.23%) of all-cause abrasion, including 75 reports (1.89%) of externalised conductors, for Australia.
St Jude Medical has recently updated the world-wide rates of reporting for insulation problems. More than 227,000 Riata and Riata ST silicone cardiac leads were supplied world-wide. To 28 February 2013, the reported rate of all-cause abrasion was 2.07% (up from 0.63% at 30 November 2011) and the reported rate of externalised conductors was 1.32% (up from 0.10% at 30 November 2011).
Updated evaluation data has not changed the information or patient management recommendations regarding Riata and Riata ST silicone cardiac leads previously issued by St Jude Medical and published on the TGA website.
If an ICD patient experiences symptoms that could indicate that the device is delivering unnecessary additional electrical charges, failing to operate when needed, or failing to provide effective therapy, they should follow the recommendations provided by the cardiologist who is responsible for their ICD management and follow-up. This may include immediately attending the nearest Emergency Room and/or contacting their cardiologist.
Based on reported rates of insulation problems and the risks associated with explantation, prophylactic replacement of affected leads is not recommended in the absence of evidence of a fault.
Patients with an affected lead should be monitored at least every 3-6 months, in accordance with the product labelling. Particular attention should be directed to diagnostic information related to the lead's performance. Any significant changes from the patient's previous follow-up visits should be investigated further.
If evidence of lead electrical failure is identified, the patient should be managed in accordance with standard practice, which may include X-ray or fluoroscopy.
Clinical decisions should be based on the individual patient’s conditions and circumstances.
Health professionals are reminded of the importance of following the manufacturer’s Instructions for Use (IFU) when using introducer spikes/trocars for accessing ports of blood collection packs.
The TGA's Incident Report Investigation Scheme (IRIS) has investigated a report of particulate matter being found in a blood collection pack. The particulate matter has been identified as material from the stopper that seals the pack.
It has been identified that with this particular blood collection pack, if the introducer spike is twisted greater than 90 degrees, particulate matter may be created and enter the pack.
The IFU for that blood collection pack has been updated to more clearly describe the correct technique for spiking the pack and to promote the use of a 170-260 micron filter when administering collected blood product.
The correct method for spiking differs between blood collection packs, so users should ensure that they read and understand the IFU documents for each pack before use.
Complying with the IFU will help to ensure that the blood collection pack performs as intended and reduce the risk of an adverse event occurring.
Anaesthetists and other health professionals are advised that, despite the removal of a warning label from the packaging of certain models of the Frova intubating catheter/introducer, those devices should still not be used with double lumen endotracheal or endobronchial tubes.
An adverse event reported to the TGA in 2003 led to the addition of the warning label, as using the device with double lumen endotracheal or endobronchial tubes can result in small fragments of the introducer being shaved off during removal.
This information has always been provided in the Instructions for Use, under the 'Intended Use' and 'Warning' sections of affected models.
The manufacturer's decision to remove the warning label was based on the fact that, since the addition of the warning label in 2003, there had been no increase in the rate of reporting of this issue and no injuries had been reported.
The sponsor issued a safety alert regarding this issue in January 2013.
Between 2003 and 2013, the TGA received two additional adverse event reports associated with this issue.
The affected models are:
Anaesthetists and other health professionals are encouraged to report all adverse events involving Frova intubating catheters/introducers to the TGA.
The TGA encourages the reporting of any suspected adverse event or potential adverse event relating to a medical device. Adverse events can involve actual harm to a patient or caregiver, or a near miss that may have resulted in harm.
Some issues relating to medical devices that may lead to adverse events and prompt you to report include:
- mechanical or material failure
- design issues
- labelling, packaging or manufacturing deficiencies
- software deficiencies
- device interactions
- user/systemic errors.
Suspected adverse events or near misses can be reported directly to the TGA:
- online at Report a problem
- by emailing email@example.com
- by mail to IRIS, TGA, PO Box 100, Woden ACT 2606
- by fax to 02 6203 1713.
For more information about reporting, visit www.tga.gov.au or contact the TGA's Office of Product Review on 1800 809 361.
The Medical Devices Safety Update (MDSU) is aimed at health professionals and is intended to provide practical information on medical device safety, including emerging safety issues. The information in the MDSU is necessarily general and is not intended to be a substitute for a health professional’s judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Therapeutic Goods Administration gives no warranty that the information in this document is accurate or complete, and does not accept liability for any injury, loss or damage whatsoever, due to negligence or otherwise, arising from the use of or reliance on the information provided in this document.
© Commonwealth of Australia 2013
This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to firstname.lastname@example.org.
For the latest information from the TGA, subscribe to the TGA Safety Information email list.
For correspondence or further information about Medical Devices Safety Update, contact the TGA's Office of Product Review at email@example.com or 1800 809 361.
Medical Devices Safety Update is written by staff from the Office of Product Review.
Editor: Dr Katherine Gray
Deputy Editor: Mr Michael Pittman
TGA Principal Medical Adviser: Dr Tony Hobbs
Contributors include Mr Trent Greentree, Ms Anne Howatt