OPTISITE ARTERIAL CANNULA

Description of Event or Problem

EDWARDS RECEIVED A REPORT WHERE AN OPTI18 CANNULA INSERTED 55 DAYS AGO HAD A DEFECT OBSERVED PROBABLY 2-3 WEEKS AFTER INSERTION AND GOT PROGRESSIVELY WORSE TO THE POINT WHERE THE CANNULA WAS REPLACED. IT WAS BEING USED FOR ECMO, INSERTED INTO THE AORTA. USED FOR 55 DAYS TOTAL. THE CANNULA WAS FOUND TO BE KINKED ON JULY 10 AND REMOVED ON JULY 11. NO INJURY TO THE PATIENT, BUT THE PATIENT DID HAVE TO BE PLACED ON CARDIOPULMONARY BYPASS FOR DEVICE REMOVAL AND REPLACEMENT. A RESPONSE IS REQUESTED. THE LOT IS UNKNOWN, BUT THE DEVICE IS AVAILABLE FOR RETURN. PER THE SALES REPRESENTATIVE, THE MAIN CONCERN WAS THE POSSIBILITY THAT THE CANNULA WAS GOING TO RUPTURE. PER ADDITIONAL INFORMATION: EDWARDS CANNULA WAS PLACED THROUGH A TUBE GRAFT THAT WAS SEWN ONTO THE SIDE OF THE AORTA. THIS TECHNIQUE IS OFTEN USED FOR LONG-TERM SUPPORT/ TISSUE STABILIZATION. THERE WERE NO OTHER ABNORMALITIES NOTED ON THE OPTI PRIOR/ DURING/ OR AFTER USE.

Additional Manufacturer Narrative

A4 PATIENT WEIGHT INFORMATION ADDED. DESCRIPTION OF EVENT ALSO UPDATED WITH ADDITIONAL INFORMATION. OTHER SECTIONS UPDATED ACCORDINGLY FOR FOLLOW UP. INCLUDING H6 INVESTIGATION FINDINGS AND CONCLUSIONS. H11 MANUFACTURER NARRATIVE: PER THE INVESTIGATION SUMMARY, BASED ON THE AVAILABLE INFORMATION, THE KINKING OBSERVED WAS CONFIRMED VIA PRODUCT EVALUATION AND IS MOST LIKELY DUE TO FORCES ON THE PRODUCT WHILE IN USE FOR MORE THAN THE 6 HOUR LIMIT STATED IN THE INSTRUCTIONS FOR USE (IFU). THE INSTRUCTIONS FOR USE STATE, "THIS DEVICE IS INTENDED FOR SHORT-TERM USE ONLY (< 6 HOURS)." THE ASSIGNABLE CAUSE FOR THIS COMPLAINT IS USE ERROR AS THE DEVICE WAS USED DIRECTLY AGAINST THE IFU. THE EXPOSED WIRE FOUND DURING EVALUATION WAS NOT REPORTED AS PART OF THE COMPLAINT AND THUS A CAUSE FOR THAT DEFECT CANNOT BE DETERMINED. IT IS POSSIBLE THAT THE DEFECT MAY HAVE OCCURRED DURING SHIPPING/ HANDLING FOR EVALUATION. THE DHR/ LOT HISTORY COULD NOT BE REVIEWED AS NO LOT NUMBER WAS PROVIDED. HOWEVER, MITIGATIONS DO EXIST IN RELATION TO THE DEFECTS REPORTED/ FOUND. RISK DOCUMENTATION/ LABELLING ARE CONSIDERED ADEQUATE. THERE IS NO EVIDENCE OF AN EDWARDS/ SUPPLIER NONCONFORMANCE. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

Additional Manufacturer Narrative

H11 MANUFACTURER NARRATIVE: PRODUCT EVALUATION - CUSTOMER REPORT OF KINKED OPTISITE CANNULA WAS CONFIRMED. CANNULA WAS OBSERVED TO HAVE MULTIPLE KINKS ALONG THE WIRE-REINFORCEMENT SECTION OF THE CANNULA BODY, APPROXIMATELY 2.5", 4.6", AND 6" FROM THE DISTAL END. AS RECEIVED, 4MM SECTION OF WIRE FROM THE WIRE REINFORCEMENT OF THE CANNULA WAS FOUND TO BE EXPOSED AND PROTRUDING FROM THE CANNULA BODY 15MM FROM DISTAL TIP UNDER THE ATTACHED CONDUIT. NO OTHER VISUAL DAMAGE, CONTAMINATION, OR OTHER ABNORMALITIES WERE FOUND TO THE CANNULA. PHOTO PROVIDED APPEARED CONSISTENT WITH LAB FINDINGS OF KINKED CANNULA. PER THE INSTRUCTIONS FOR USE, THE EDWARDS LIFESCIENCES ARTERIAL PERFUSION CANNULA ARE INDICATED FOR ARTERIAL PERFUSION IN THE EXTRACORPOREAL CIRCUIT FOR LESS THAN 6 HOURS. THE USE IN THIS CASE OF MULTIPLE WEEKS IS CONSIDERED OFF LABEL USE. THE REPORTED EVENT IS PENDING FURTHER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN A TIMELY MANNER ONCE THE INVESTIGATION HAS BEEN COMPLETED OR NEW INFORMATION BECOMES AVAILABLE. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

Description of Event or Problem

EDWARDS RECEIVED A REPORT WHERE AN OPTI18 CANNULA INSERTED 55 DAYS AGO. THE DEFECT WAS OBSERVED PROBABLY 2-3 WEEKS AFTER INSERTION AND GOT PROGRESSIVELY WORSE TO THE POINT WHERE THE CANNULA WAS REPLACED. IT WAS BEING USED FOR ECMO, INSERTED INTO THE AORTA. USED FOR 55 DAYS TOTAL. THE CANNULA WAS AGAIN FOUND TO BE KINKED AND THEN REPLACED THE FOLLOWING DATE. NO INJURY TO THE PATIENT, BUT THE PATIENT DID HAVE TO BE PLACED ON CARDIOPULMONARY BYPASS FOR DEVICE REMOVAL AND REPLACEMENT. A RESPONSE IS REQUESTED. THE LOT IS UNKNOWN, BUT THE DEVICE IS AVAILABLE FOR RETURN. PER THE SALES REPRESENTATIVE, THE MAIN CONCERN WAS THE POSSIBILITY THAT THE CANNULA WAS GOING TO RUPTURE. PER PRODUCT EVALUATION, CUSTOMER REPORT OF KINKED OPTISITE CANNULA WAS CONFIRMED. CANNULA WAS OBSERVED TO HAVE MULTIPLE KINKS ALONG THE WIRE-REINFORCEMENT SECTION OF THE CANNULA BODY. AS RECEIVED, 4MM SECTION OF WIRE FROM THE WIRE REINFORCEMENT OF THE CANNULA WAS FOUND TO BE EXPOSED AND PROTRUDING FROM THE CANNULA BODY 15MM FROM DISTAL TIP UNDER THE ATTACHED CONDUIT. NO OTHER VISUAL DAMAGE, CONTAMINATION, OR OTHER ABNORMALITIES WERE FOUND TO THE CANNULA. PHOTO PROVIDED APPEARED CONSISTENT WITH LAB FINDINGS OF KINKED CANNULA.