Deaths caused by the failure of Riata and Riata ST implantable cardioverter-defibrillator leads

Fluoroscopic investigation of Riata® transvenous defibrillator leads

“…Clearly the prevalence of lead externalization is high in the range of > 20% as shown by ours and recent other studies. Most of the visual lead defects are electrically silent on a routine interrogation but stakes are high as demonstrated by failed device therapy delivery for arrhythmias and by the deaths reported in the study from Hauser et al [8]. Our study showed that over time, electrical parameters do show a trend towards higher pacing thresholds in leads with extruded conductors, however the timing and ultimate outcome of these changes remain unknown and at the present can't be used to dictate clinical practice.…”

“…Earlier studies have shown a low rate of lead insulation failure (< 1%) but these studies were limited due to the way insulation failure were analyzed (no consistent fluoroscopy) or shorter period of follow up [6,7]. A recent large study by Hauser et al [8] reported an alarming number of deaths in patients implanted with Riata ® and Riata ® ST leads primarily associated with failed defibrillation. A number of other reports have indicated that the actual prevalence of this unique "inside-out" abrasion defect is higher than that of previous reports, citing rates of insulation breach of around 20-33% when examined by a systematic fluoroscopic approach [9][10][11].…”

A Primer to the Structure, Content and Linkage of the FDA’s Manufacturer and User Facility Device Experience (MAUDE) Files

“…MAUDE has facilitated the identification and investigation of medical product problems ranging from cardiovascular and gynecological devices to stretchers and tanning beds. [4][5][6][7][8][9][10][11][12][13] While the FDA's online MAUDE search engine provides a targeted way to look up small numbers of adverse event reports associated with specific products or problems, the search results are limited to the past 10 years and detailed information is not structured in a format that can be readily analyzed. In addition, the number of records returned for a given query is capped, and in a small sample study nearly half of the search results exceeded this limit.…”

Cable externalization at the proximal portion of the superior vena cava coil in Riata implantable cardioverter defibrillator leads

“…Although the relationship between electrical abnormalities and cable externalization has not been proven, insulation defects might induce high-voltage failures. 1) The common sites of cable externalization of Riata ICD leads are reportedly at the lead-can or between the two coils, and underneath the shocking coil. 2)3) Here we describe a case of cable externalization in a Riata ICD lead at the proximal portion of the superior vena cava (SVC) coil.…”