Abstract
European regulatory authorities issued Medical Device Alerts relating to the performance of Riata® and Riata® ST Silicone Defibrillation Leads in December 2010. 12 months later, in USA St. Jude Medical, Inc. has now announced that following its voluntary medical device advisory letter to physicians from Nov. 28, 2011 the U.S. Food and Drug Administration (FDA) has now classified this action as a Class I Recall.
Background
In December 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA), in common with other regulatory competent authorities in Europe, issued a Medical Device Alert(MDA) pertaining to iterations of St Jude Medical’s Riata and Riata ST silicone defibrillation leads. At the same time St Jude Medical ceased supplying Riata and Riata ST implantable defibrillator leads not featuring its new “Optim” insulation.
On November 28th 2011, St Jude Medical undertook a voluntary recall of its Riata® and Riata® ST Silicone Defibrillation Leads in USA. In its advisory letter to physicians the company stated; “New peer reviewed literature from one single center site in Belfast, Northern Ireland, has indicated a 15% incidence rate of externalized conductors in Riata silicone leads (25 out of 165 patients) during fluoroscopic screening, including 5 leads (3%) that were associated with an electrical abnormality. One significant finding out of the Belfast experience is that a large percentage (35%) of the patients with Riata leads at the site had Riata (8Fr) single shock coil models. Analysis of worldwide complaint and returns information has identified that Riata (8Fr) single shock coil models exhibit a significantly higher incidence rate of externalized conductors than all other Riata (8Fr) and Riata ST (7Fr) models, which helps explain why the Belfast experience has shown such a high incidence rate.”
When a manufacturer issues an advisory letter to physicians in the United States, FDA is procedurally obliged to classify that advisory activity. On this occasion the FDA has classified the action as a Class I recall because of the potential risk of serious injury or patient death if affected devices malfunction.
Affected products
In (UK) MHRA’s alert notice of December 16th last year it reported 39 incidents of insulation failure against sales of approximately 4500 units in UK since 2002.
An estimated 79,000 Riata and Riata ST family of silicone leads remain active in patients in the U.S. The company stopped distributing the Riata and Riata ST family of silicone leads in December 2010. The affected model numbers are the Riata (8F) Silicone Endocardial Defibrillation Leads (Models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, and 1592), and the Riata ST (7Fr) Silicone Endocardial Defibrillation Leads (Models 7000, 7001, 7002, 7010, 7011, 7040, 7041, and 7042).
In 2006, the manufacturer improved the insulation for new Riata leads. New leads are known as Riata ST Optim. The manufacturer has provided data on Riata ST Optim leads that suggests an 80% reduction in the rate of abrasion-related failure at 44 months post-implantation, compared with the previous design.
Implications
The company claims that clinical implications of externalized conductors in a defibrillation lead without electrical anomalies are not fully known or understood at this time. Externalized conductors can present as only a visual observation on x-ray or fluoroscopy without any associated clinical or device-related observations. If the electrical integrity of a lead were to be compromised, failure to deliver appropriate therapy, or the delivery of inappropriate therapy, could potentially occur, and could lead to a serious adverse event or death. Reports to St. Jude Medical associated with extraction of a Riata lead with externalized conductors include two patient deaths and one serious injury (effusion requiring thoracotomy). In addition, one patient death and one serious injury in patients with externalized conductors were reported, but were determined not to be due to the presence of externalized conductors.
Action required
The action from MHRA’s MDA of 12 months ago was due to be completed by March 2011, so it’s unlikely that European actions are still underway. Even so its worth recapping that MHRA guidance suggested responsible clinicians should identify all patients implanted with Riata or Riata ST ICD lead models as listed and arrange for follow-up at three-month intervals to review lead performance following standard procedures. They were also advised to remind patients of the importance of contacting their follow-up clinic as soon as possible in the event of therapy delivery and/or the onset of any audible patient alert. Finally they were to report all lead adverse incidents to the MHRA and to St Jude Medical. Note that prophylactic removal of leads was not being recommended other than in exceptional circumstances.
In its USA advisory almost a year later St. Jude Medical reiterates that all leads with an externalized conductor, with or without an associated electrical abnormality, be reported to the company’s Technical Services Department at 1-800-722-3774 . The company also strongly encourages that any experience with screening of Riata leads for externalized conductors be shared with the company, including information regarding a lead or leads in which externalized conductors are not present. The company is also requesting that any leads removed from patients be returned to the company, at company expense, for failure analysis to further understand this particular failure mechanism. All reports and returns received by St. Jude Medical of Riata leads exhibiting externalized conductors, irrespective of whether there is an associated electrical abnormality, will be reported to FDA as a Medical Device Report (MDR). (Any adverse reactions experienced with the use of this product in USA, and/or quality problems also should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088 , by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.)
The US press release regarding the advisory letter to physicians, including required actions can be found here. The MHRA MDA from December 2010 can be found here.
Source: MHRA, FDA
published: December 19, 2011 in: Alerts/Adverse Events, Cardio, Regulatory, St Jude, USA