BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U

    MDR report key: 10736647 · Received October 26, 2020

    Report

    Report Number
    2015691-2020-14141
    Event Type
    Death
    Date Received
    October 26, 2020
    Date of Event
    October 1, 2020
    Report Date
    October 1, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. IMAGERY WAS PROVIDED AND CINE IMAGES REVEALED THE CRIMPED VALVE WITH BENT STRUT EXITING THE SHEATH. THE PATIENT¿S ACCESS VESSEL HAD MILD CALCIFICATION AND SOME TORTUOSITY. IMAGERY PROVIDED ALSO SHOWS THE FRAME STRUT PROTRUDING THROUGH THE STRAIN RELIEF. BASED ON THE IMAGERY PROVIDED THE EVENTS CAN BE CONFIRMED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. A LOT HISTORY REVIEW WAS PERFORMED AND REVEALED NO OTHER SIMILAR COMPLAINTS. A REVIEW OF COMPLAINT HISTORY FROM (B)(6) 2019 TO (B)(6) 2020 FOR ALL MODELS REVEALED OTHER RETURNED COMPLAINTS FOR DELIVERY SYSTEM WITHDRAWAL DIFFICULTIES THROUGH SHEATH. THE COMPLAINTS WERE REVIEWED BASED ON SIMILAR REPORTED EVENTS AND ASSOCIATED ROOT CAUSES / EVALUATION CODES. OF THESE POTENTIAL ROOT CAUSES, THE FOLLOWING ARE APPLICABLE TO THE CURRENT EVALUATION: PATIENT FACTORS (ACCESS VESSEL TORTUOSITY AND CALCIFICATION) AND PROCEDURAL FACTORS (WITHDRAWAL OF BENT VALVE). THE INSTRUCTIONS FOR USE (IFU), DEVICE PREPARATION TRAINING MANUAL, AND DEVICE PROCEDURAL TRAINING MANUAL WERE REVIEWED FOR GUIDANCE AND INSTRUCTION INVOLVING THE ESHEATH AND DELIVERY SYSTEM USAGE. THE THV CAN BE RETRIEVED THROUGH SHEATH ONLY BEFORE THV DEPLOYMENT (STILL CRIMPED). ENSURE THE THV IS CENTERED ON THE FLEX TIP AND THE DELIVERY SYSTEM IS LOCKED. VERIFY THE FLEX CATHETER IS COMPLETELY UNFLEXED. RETRACT THE THV AND DELIVERY SYSTEM INTO THE SHEATH ENSURING THE THV IS COMPLETELY INSIDE THE SHEATH AND JUST PAST THE SHEATH TIP. ENSURE THE EDWARDS LOGO ON THE SHEATH HANDLE IS FACING UPWARD. WITHDRAW THE DELIVERY SYSTEM AND SHEATH AS A SINGLE UNIT COMPLETELY FROM THE ARTERIOTOMY WHILE MAINTAINING GUIDEWIRE POSITION. DO NOT RE-USE THE SHEATH, THV OR DELIVERY SYSTEM ONCE THV IS RETRIEVED. CRIMPED THV ALIGNED ON BALLOON IS LARGER THAN CRIMPED THV OFF BALLOON. TAKE CARE IF DECIDING TO RETRIEVE. DO NOT FORCE THE THV INTO THE SHEATH. IF RESISTANCE IS FELT, THE THV MAY BE CAUGHT ON THE SHEATH TIP. STOP, ADVANCE THV PAST THE SHEATH TIP AND ENSURE THV IS CENTERED ON THE FLEX TIP. ROTATE THE DELIVERY SYSTEM BEFORE TRYING AGAIN. RETRIEVABILITY IS BASED ON PRECLINICAL TESTING. BASED ON THE REVIEW OF THE IFU/TRAINING MANUALS, NO DEFICIENCIES WERE IDENTIFIED. DURING MANUFACTURING OF THE COMMANDER DELIVERY SYSTEM, THE DELIVERY SYSTEM AND COMPONENTS ARE INSPECTED SEVERAL TIMES THROUGHOUT THE MANUFACTURING PROCESS. IN ADDITION, PRODUCT VERIFICATION TESTING WAS PERFORMED ON A SAMPLING BASIS AND ALL TESTING MET SPECIFICATIONS. THESE INSPECTIONS PERFORMED DURING MANUFACTURING PROCESS AND TESTING PERFORMED DURING PRODUCT VERIFICATION SUPPORT THAT IT IS UNLIKELY THAT A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE REPORTED EVENTS. THE COMPLAINT FOR ¿DELIVERY SYSTEM ¿ WITHDRAWAL DIFFICULTY-VALVE, THROUGH SHEATH¿ WAS CONFIRMED BASED ON THE IMAGERY PROVIDED. DUE TO THE DEVICE WAS NOT RETURNED FOR EVALUATION, ENGINEERING WAS UNABLE TO PERFORM ANY VISUAL, FUNCTIONAL, OR DIMENSIONAL ANALYSIS. THEREFORE, A POTENTIAL MANUFACTURING NONCONFORMANCE WAS UNABLE TO BE DETERMINED. HOWEVER, BASED ON A REVIEW OF THE DHR AND LOT HISTORY, THERE IS NO EVIDENCE INDICATING THAT A MANUFACTURING NON-CONFORMANCE COULD HAVE CONTRIBUTED TO THE COMPLAINT EVENTS. NO IFU/TRAINING MANUAL DEFICIENCIES WERE IDENTIFIED. PER THE COMPLAINT DESCRIPTION, ¿THERE WAS A LOT OF RESISTANCE WHEN PASSING THE DELIVERY SYSTEM WITH THE CRIMPED VALVE THROUGH THE SHEATH, AND ONE OF THE VALVE STRUTS BENT AND REMAINED PERPENDICULAR TO THE DIRECTION OF THE PROSTHESIS, PROTRUDING FROM THE SHEATH.¿ PER THE PROVIDED IMAGERIES, THE PATIENT¿S ACCESS VASCULATURE WAS TORTUOUS AND HAD MILD CALCIFICATION. TORTUOSITY CAN CREATE A CHALLENGING PATHWAY FOR RETRIEVING THE SYSTEM. IN ADDITION, THE PRESENCE OF CALCIFICATION CAN CREATE THE RESISTANCE DURING THE INSERTION OR WITHDRAWAL OF THE DELIVERY SYSTEM THROUGH THE SHEATH. FINALLY, THE VALVE APPEARED TO HAVE A BENT STRUT. THIS ALTERED PROFILE OF THE VALVE MAY HAVE ALSO BEEN A CONTRIBUTING FACTOR TO THE DIFFICULTY EXPERIENCED WHEN RETRIEVING THE VALVE THROUGH THE SHEATH, AS THE THV MAY BE SUSCEPTIBLE TO CATCHING ON OTHER SURFACES. AVAILABLE INFORMATION SUGGESTS PATIENT (CALCIFICATION/TORTUOSITY) AND PROCEDURAL FACTORS (WITHDRAWAL OF BENT VALVE STRUT) MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. IN THIS CASE, A ILIAC ARTERY RUPTURE OCCURRED AND WAS POSSIBLY DUE TO PROCEDURAL FACTORS (DEVICE MANIPULATION) AND/OR SEVERE CALCIFICATION OF THE ACCESS VESSEL THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. 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. 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. SINCE NO EDWARDS DEFECT, WHICH COULD HAVE RESULTED IN THE COMPLAINT, WAS CONFIRMED, NO PREVENTATIVE OR CORRECTIVE ACTIONS ARE REQUIRED. ADDITIONALLY, SINCE NO PRODUCT NON-CONFORMANCE WAS CONFIRMED, A PRODUCT RISK ASSESSMENT (PRA) IS NOT REQUIRED.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2020-14140. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS EUROPEAN AFFILIATE, THE PATIENT UNDERWENT IMPLANT OF A 26MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION BY TRANSFEMORAL APPROACH. THERE WAS A LOT OF RESISTANCE WHEN PASSING THE DELIVERY SYSTEM WITH THE CRIMPED VALVE THROUGH THE SHEATH AND ONE OF THE VALVE STRUTS BENT AND REMAINED PERPENDICULAR TO THE DIRECTION OF THE PROSTHESIS, PROTRUDING FROM THE SHEATH. THERE WAS AN ILIAC ARTERY RUPTURE DUE TO THE BENT STRUT. DUE TO THE INJURY, THERE WAS A RETROPERITONEAL BLEEDING. THE OPERATORS TRIED TO INTUBATE THE PATIENT, HOWEVER AIR WENT TO THE STOMACH INSTEAD OF THE LUNGS. CPR WAS REQUIRED. THE PATIENT UNDERWENT VASCULAR SURGERY TO REPAIR THE DAMAGE IN THE ILIAC AND THE VASCULAR SURGEONS DECIDED NOT TO REMOVE THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS CUT AND THE DISTAL PART OF IT WAS LEFT IN THE PATIENT´S ARTERY AND THEN A VASCULAR BYPASS WAS DONE. THE PATIENT WAS MOVED TO UCI AND WAS THERE 2-3 DAYS. THE PATIENT STARTED SHOWING SIGNS OF MYOCLONUS AND EXPIRED THREE DAYS AFTER THE TAVI PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200164 EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9610TF26U 62988211

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R