EDWARDS ESHEATH INTRODUCER SET
Report
- Report Number
- 2015691-2024-04997
- Event Type
- Death
- Date Received
- July 1, 2024
- Date of Event
- June 12, 2024
- Report Date
- July 23, 2024
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DYB
- UDI-DI
- 00690103193244
- PMA / PMN Number
- K200258
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE WAS RETURNED FOR EVALUATION AND AN ENGINEERING EVALUATION WAS PERFORMED. THE DEVICE WAS VISUALLY EXAMINED, AND THE FOLLOWING WAS OBSERVED: THE LINER WAS FULLY EXPANDED. THE DISTAL TIP WAS OPENED AS DESIGNED. THE LINER WAS TORN ALONG THE ENTIRE LENGTH. ONE (1) LINER STRAND WAS PRESENT, APPROXIMATELY 12CM FROM DISTAL TIP, WITH A LENGTH OF APPROXIMATELY 9CM. SCRATCHES WERE PRESENT ALONG ENTIRETY OF SHEATH SHAFT. THE HDPE WAS FOLDED INWARDS IN THE MIDDLE OF THE SHEATH SHAFT. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THE FAILURE MODE IS NOT REQUIRED AT THIS TIME. THE COMPLAINTS OF SHEATH LINER PUNCTURED AND SHEATH LINER STRAND WERE CONFIRMED BASED ON THE RETURNED PRODUCT EVALUATION AND PROVIDED IMAGERY. HOWEVER, NO MANUFACTURING NON-CONFORMANCE WAS IDENTIFIED DURING THE EVALUATION. A REVIEW OF THE DHR DID NOT PROVIDE ANY INDICATION THAT A MANUFACTURING NON-CONFORMANCE WOULD HAVE CONTRIBUTED TO THE COMPLAINT EVENT. A REVIEW OF IFU/TRAINING MATERIALS REVEALED NO DEFICIENCIES. FURTHERMORE, NO ABNORMALITIES WERE NOTED DURING DEVICE UNPACKING OR PREPARATION. AS REPORTED, ''THE PATIENT'S FEMORAL AXES SHOWED MODERATE CALCIFICATIONS AND TORTUOSITY, THE AORTA WAS NOT PORCELAIN AND THE RIGHT FEMORAL ARTERY HAD A DIAMETER OF 7 MM [...] WHILE ADVANCING THE S3 29MM VALVE THROUGH THE EDWARDS INTRODUCER, [THE PATIENT WAS NERVOUS AND MOVING A LOT AND KICKING HIS LEGS WHEN THE VALVE WAS GOING THROUGH THE INTRODUCER], [THE PHYSICIAN] EXPERIENCED AN ISSUE WHEN THE VALVE, JUST AS IT WAS ABOUT TO EXIT THE INTRODUCER, PERFORATED THE INTRODUCER AND THE PATIENT'S ABDOMINAL AORTA. DURING ATTEMPTS TO REMOVE THE VALVE FROM THE INTRODUCER, IT TORE BOTH THE INTRODUCER AND THE PATIENT'S ILIAC ARTERY [...] SIGNIFICANT DIFFICULTIES WERE FOUND WHILE WITHDRAWING THE COMMANDER DELIVERY SYSTEM AND VALVE, THE VALVE GOT STUCK WITHIN THE DISTAL PART OF THE ESHEATH AND DISLODGED FROM THE COMMANDER DELIVERY SYSTEM, AT THE ESHEATH AND ILIAC ARTERY TORE. THE VALVE WAS PUSHED OUT OF THE ESHEATH. A VASCULAR CUT-DOWN WAS PERFORMED TO REMOVE THE COMMANDER DELIVERY SYSTEM, BUT THE VALVE REMAIN INSIDE THE PATIENT WHICH WAS SURGICALLY RETRIEVED.'' FOR THE COMPLIANT OF LINER PUNCTURED, THE DIMENSIONAL INSPECTION OF THE RETURNED SHEATH REVEALED THAT THE LINER WALL THICKNESS ALONG THE LINER TEAR WAS WITHIN SPECIFICATION. AN EXISTING TECHNICAL SUMMARY TECHNICAL SUMMARY HAS BEEN DOCUMENTED FOR ROOT CAUSE ANALYSIS ON SHEATH SHAFT LINER TEARS WITH NORMAL LINER EXPANSION. IN THIS TECHNICAL SUMMARY, A REVIEW OF LINER TEAR COMPLAINT INVESTIGATIONS ON RETURNED DEVICES OVER A TWO-YEAR PERIOD FOUND THAT PATIENT / PROCEDURAL FACTORS (E.G. ACCESS VESSEL TORTUOSITY / CALCIFICATION OR WITHDRAWAL OF A BURST OR TORN BALLOON) ARE LIKELY THE CONTRIBUTING FACTORS FOR SHEATH SHAFT LINER TEARS. PER THE EVENT DESCRIPTION, ''THE PATIENT'S FEMORAL AXES SHOWED MODERATE CALCIFICATIONS AND TORTUOSITY''. ADDITIONALLY, EVALUATION OF THE RETURNED DEVICE SHOWED SCRATCHES ALONG THE SHEATH SHAFT, SUGGESTING PRESENCE OF CALCIFICATION WITHIN THE ACCESS VESSEL. CALCIFICATION CAN DAMAGE THE EXPOSED PORTION OF THE SHEATH LINER. DAMAGE ALONG THE LINER COULD LEAD TO IMMEDIATE CUTTING/TEARING OR COULD WEAKEN THE LINER. A WEAKENED LINER CAN TEAR DURING ADVANCEMENT OR RETRIEVAL OF THE DELIVERY SYSTEM. CALCIFICATION AND TORTUOSITY CAN CREATE SUBOPTIMAL ANGLES THAT CAN LEAD TO NON-COAXIAL ALIGNMENT BETWEEN THE DEVICES DURING DELIVERY SYSTEM ADVANCEMENT THROUGH THE SHEATH. THE DELIVERY SYSTEM BALLOON CATHETER OR CRIMPED VALVE CAN POTENTIALLY CATCH ON TO THE LINER OF THE SHEATH AND TEAR THE LINER DURING ADVANCEMENT OR WITHDRAWAL THROUGH THE SHEATH. THE DELIVERY SYSTEM OR CRIMPED VALVE CAN THEN EXIT THE INNER SHEATH LUMEN THROUGH THE TORN SHEATH LINER. IN ADDITION, IT WAS REPORTED THAT ''SIGNIFICANT DIFFICULTIES WERE FOUND WHILE WITHDRAWING THE COMMANDER DELIVERY SYSTEM AND VALVE, THE VALVE GOT STUCK WITHIN THE DISTAL PART OF THE ESHEATH''. THIS LIKELY LED TO HIGH PULL FORCES WHEN ATTEMPTING TO WITHDRAW THE DELIVERY SYSTEM AND CRIMPED VALVE THROUGH THE SHEATH, WHICH CAN FURTHER CONTRIBUTE TO THE LINER DAMAGE. THE TECHNICAL SUMMARY DEMONSTRATED THAT THERE WERE NO DEFICIENCIES IN THE IFU/TRAINING MANUALS AND OUTLINES THE EXTENSIVE MANUFACTURING MITIGATIONS IN PLACE TO DETECT A DEFECT OR NONCONFORMANCE ASSOCIATED WITH SHEATH SHAFT LINER TEARS. THERE ARE SEVERAL 100% IN-PROCESS INSPECTIONS (VISUAL) PERFORMED IN MANUFACTURING PROCESS AND PRODUCT VERIFICATION TESTING (FUNCTIONAL AND VISUAL) ON A SAMPLING PLAN BASIS PERFORMED PRIOR TO LOT RELEASE. IT SHOULD BE NOTED THAT THESE MITIGATIONS (FROM MANUFACTURING AND THE IFU/TRAINING MANUAL), AS IDENTIFIED IN THE TECHNICAL SUMMARY, ARE STILL IN PLACE. AS SUCH, THESE INSPECTIONS AND TESTING SUPPORT THAT IT IS UNLIKELY THAT A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE COMPLAINT. AS SUCH, AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (CALCIFICATION, TORTUOSITY) AND/OR PROCEDURAL FACTORS (VALVE CAUGHT ON LINER, HIGH PULL FORCE) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT LEADING TO THE SUBSEQUENT VASCULAR INJURY AND DEATH. SINCE NO EDWARDS DEFECT WAS IDENTIFIED, NO CORRECTIVE OR PREVENTATIVE ACTION, NOR PRODUCT RISK ASSESSMENT IS REQUIRED . FOR THE COMPLAINT OF SHEATH LINER STRAND, VESSEL CALCIFICATION AND/OR TORTUOSITY CAN EXASPERATE THE INTERACTION BETWEEN THE CRIMPED VALVE AND SHEATH. SHARP CALCIFIED NODULES CAN DIRECTLY WEAKEN THE LINER MAKING IT MORE SUSCEPTIBLE TO DAMAGE AS THE DELIVERY SYSTEM WITH CRIMPED VALVE IS ADVANCED THROUGH. CALCIFICATION AND TORTUOSITY CAN CREATE SUBOPTIMAL ANGLES THAT CAN LEAD TO NON-COAXIAL ALIGNMENT BETWEEN THE DEVICES DURING DELIVERY SYSTEM ADVANCEMENT THROUGH THE SHEATH. THIS CAN LEAD TO THE CRIMPED VALVE TO CATCH ONTO THE SHEATH HDPE AND/OR LINER AND LEAD TO DAMAGE, SUCH AS THE OBSERVED LINER STRAND. ADDITIONALLY, THE DIFFICULTY THAT WAS EXPERIENCED WHEN ATTEMPTING TO WITHDRAW THE SYSTEM THOUGH THE SHEATH LIKELY LED TO HIGH PULL FORCE, WHICH CAN LEAD TO FURTHER DAMAGE OF THE LINER. AS SUCH, AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (CALCIFICATION, TORTUOSITY) AND/OR PROCEDURAL FACTORS (VALVE CAUGHT ON LINER, HIGH PULL FORCE) MAY HAVE CONTRIBUTED TO THE EVENT LEADING TO THE SUBSEQUENT VASCULAR INJURY AND DEATH. HOWEVER, A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED. NO DEVICE PROBLEM OR MANUFACTURING NON-CONFORMANCE THAT WOULD HAVE CONTRIBUTED TO THE COMPLAINT EVENT WAS IDENTIFIED DURING THE EVALUATION. SINCE NO EDWARDS DEFECT WAS IDENTIFIED, NO CORRECTIVE OR PREVENTATIVE ACTION, NOR PRODUCT RISK ASSESSMENT IS REQUIRED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2024-05250.
INVESTIGATION IS ONGOING. THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE.
AS REPORTED BY AFFILIATES IN FRANCE, AN ESHEATH LINER PUNCTURE AND LINER STRAND WERE DISCOVERED POST IMPLANT OF THE 29MM SAPIEN 3 VALVE IMPLANT IN AORTIC POSITION BY TRANSFEMORAL APPROACH. THE PATIENT'S FEMORAL AXES SHOWED MODERATE CALCIFICATIONS AND TORTUOSITY, THE AORTA WAS NOT PORCELAIN AND THE RIGHT FEMORAL ARTERY HAD A DIAMETER OF 7 MM. DURING PROCEDURE, WHILE ADVANCING THE SAPIEN 3 VALVE THROUGH THE ESHEATH, JUST AS THE VALVE WAS ABOUT EXIT THE ESHEATH BY THE TIP, THE ESHEATH WAS PERFORATED BY THE VALVE AND THE PATIENT'S ABDOMINAL AORTA WAS ALSO PERFORATED. SIGNIFICANT DIFFICULTIES WERE FOUND WHILE WITHDRAWING THE COMMANDER DELIVERY SYSTEM AND VALVE, THE VALVE GOT STUCK WITHIN THE DISTAL PART OF THE ESHEATH AND DISLODGED FROM THE COMMANDER DELIVERY SYSTEM, AT THE ESHEATH AND ILIAC ARTERY TORE. THE VALVE WAS PUSHED OUT OF THE ESHEATH. A VASCULAR CUT-DOWN WAS PERFORMED TO REMOVE THE COMMANDER DELIVERY SYSTEM, BUT THE VALVE REMAINED INSIDE THE PATIENT WHICH WAS SURGICALLY RETRIEVED. TO TREAT THE VASCULAR DAMAGE A BALLOON WAS INFLATED IN THE ABDOMINAL AORTA TO STOP THE BLEEDING, BUT IT WAS INEFFICIENT. IMMEDIATE SURGICAL REPAIR WAS INITIATED TO ADDRESS THE PERFORATION OF THE ABDOMINAL AORTA AND THE ILIAC ARTERY. THE PATIENT UNDERWENT EMERGENCY VASCULAR SURGERY TO CONTROL BLEEDING AND REPAIR THE DAMAGED VESSELS WITH UNSUCCESSFUL RESULT. THE PATIENT PASSED AWAY FOLLOWING THE PERFORATION OF THE ABDOMINAL AORTA. AS PER THE DEVICE PHOTOS PROVIDED, THE ESHEATH LINER APPEARED TORN AND THERE WAS A LINER STRAND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1271033 | EDWARDS ESHEATH INTRODUCER SET | INTRODUCER, CATHETER | DYB | EDWARDS LIFESCIENCES | 9610ES16 | 65426796 | 00690103193244 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Male | Required Intervention| D |