BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U

    MDR report key: 10568585 · Received September 22, 2020

    Report

    Report Number
    2015691-2020-13680
    Event Type
    Injury
    Date Received
    September 22, 2020
    Date of Event
    August 31, 2020
    Report Date
    August 31, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE IMAGES PROVIDED WERE NOT RELATED TO THE COMPLAINT EVENT. THEREFORE, NO VISUAL, FUNCTIONAL, OR DIMENSIONAL ANALYSIS COULD BE PERFORMED. DHR REVIEW DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. A LOT HISTORY REVIEW REVEALED NO OTHER SIMILAR COMPLAINTS. THE IFU, DEVICE PREPARATION TRAINING MANUAL, AND PROCEDURAL TRAINING MANUAL WERE REVIEWED FOR INSTRUCTIONS/GUIDANCE FOR PREPARATION AND USE OF THE DEVICES. PER THE PROCEDURAL TRAINING MANUAL, DELIVERY SYSTEM REMOVAL: COMPLETELY UNFLEX THE DELIVERY SYSTEM. ENSURE FLEX TIP IS STILL OVER THE TRIPLE MARKER. ENSURE BALLOON LOCK IS LOCKED. ENSURE THE BALLOON IS COMPLETELY DEFLATED. RETRACT LOADER (IF NEEDED). PULL THE ENTIRE DELIVERY SYSTEM THROUGH THE SHEATH. MAINTAIN GUIDEWIRE POSITION IN THE AORTA. CAUTION: PATIENT INJURY COULD OCCUR IF THE DELIVERY SYSTEM IS NOT COMPLETELY UNFLEXED PRIOR TO REMOVAL. THV RETRIEVAL THROUGH SHEATH: THV CAN BE RETRIEVED THROUGH SHEATH ONLY BEFORE THV DEPLOYMENT (STILL CRIMPED). ENSURE THE THV IS CENTERED ON THE FLEX TIP. ENSURE 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. NOTE: CRIMPED THV ALIGNED ON BALLOON IS LARGER THAN CRIMPED THV OFF BALLOON. TAKE CARE IF DECIDING TO RETRIEVE. NOTE: 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. NOTE: RETRIEVABILITY IS BASED ON PRECLINICAL TESTING. BASED ON THE REVIEW OF THE IFU/TRAINING MANUALS, NO DEFICIENCIES WERE IDENTIFIED. DURING MANUFACTURING OF THE 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-CONFORMANCES CONTRIBUTED TO THE REPORTED EVENTS. THERE MAY BE CASES IN WHICH THE VALVE IS NOT ABLE TO BE DEPLOYED AT THE INTENDED LOCATION. THIS MAY REQUIRE DEPLOYING THE VALVE AT A NON-TARGET LOCATION. ALTHOUGH, GENERALLY WELL TOLERATED, THE LONG-TERM EFFECTS ARE NOT COMPLETELY UNDERSTOOD. THE COMPLAINT WAS UNABLE TO BE CONFIRMED DUE TO THE DEVICE AND APPLICABLE PHOTO NOT BEING PROVIDED FOR EVALUATION. BECAUSE 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 REPORT, THE OPERATOR ATTEMPTED TO PULL THE VALVE BACK INTO THE SHEATH AND WITHDRAWAL EVERYTHING AS A SYSTEM. HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL DUE TO THE FLARED STRUT. THE OPERATOR DID NOT WANT TO PULL THE VALVE BACK THROUGH THE SHEATH AND POSSIBLY DAMAGE THE ARTERY. IN THIS CASE, IT WAS LIKELY THE DELIVERY SYSTEM WITHDRAWAL DIFFICULTY WAS DUE TO THE BENT STRUT. THE PRESENCE OF BENT STRUTS COULD ALTER THE PROFILE (ENLARGED) OF CRIMPED VALVE, AND IT LED TO DIFFICULTY OR RESISTANCE DURING THE DELIVERY SYSTEM RETRIEVAL THROUGH THE SHEATH. AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (DELIVERY SYSTEM WITHDRAWAL WITH BENT STRUT) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. HOWEVER, A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME. THE COMPLAINT FOR ¿DELIVERY SYSTEM ¿ WITHDRAWAL DIFFICULTY-VALVE, THROUGH SHEATH¿ WAS UNABLE TO BE CONFIRMED. NO MANUFACTURING NON-CONFORMANCES WERE FOUND IN THE EVALUATION. AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (DELIVERY SYSTEM WITHDRAWAL WITH BENT VALVE STRUT) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED AND REVIEWED OF IFU/TRAINING MATERIALS REVEALED NO DEFICIENCIES. THEREFORE, NO CORRECTIVE AND PREVENTATIVE ACTION IS REQUIRED AT THIS TIME. 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.

    Additional Manufacturer Narrative · 1

    UDI NUMBER: (B)(4). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    DURING IMPLANT OF A 26MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION, THERE WAS EXTREME RESISTANCE ADVANCING THE COMMANDER DS AND VALVE THROUGH THE ESHEATH. AFTER THE VALVE PASSED THROUGH THE ESHEATH, A FLARED STRUT ON THE DISTAL END OF THE VALVE THAT LOOKED LIKE A HOOK WAS OBSERVED. THE OPERATOR ATTEMPTED TO PULL THE VALVE BACK INTO THE SHEATH AND WITHDRAWAL EVERYTHING AS A SYSTEM. HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL DUE TO THE FLARED STRUT. THE OPERATOR DID NOT WANT TO PULL THE VALVE BACK THROUGH THE SHEATH AND POSSIBLY DAMAGE THE ARTERY, SO THE VALVE WAS DEPLOYED IN THE AORTA. AFTER VALVE DEPLOYMENT A PERFORATION WAS OBSERVED AND A COVERED STENT WAS USED TO SEAL THE AORTA. THE PERFORATION WAS COVERED AND FLOW WAS RESTORED. A SECOND 26MM SAPIEN 3 ULTRA VALVE WAS PREPPED AND SUCCESSFULLY IMPLANTED. THE PATIENT WAS STABLE AFTER THE CASE. THE ACCESS VESSEL MLD WAS 7.4/8.6, WAS NOT VERY TORTUROUS, AND NOT MUCH CALCIFICATION. THE VESSEL WAS NOT PRE-DILATED. THERE WERE SOME SCRATCHES ON THE SHEATH. THE LOADER WAS ABLE TO BE FULLY INSERTED INTO THE SHEATH/SHEATH HOUSING. IT WAS UNKNOWN IF THE SHEATH WAS INSERTED AT A STEEP ANGLE. THE DELIVERY SYSTEM WAS JUST PAST THE SHEATH HOUSING WHEN THE DIFFICULTY WAS EXPERIENCED. THE DELIVERY SYSTEM WAS IN DEFAULT POSITION DURING INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033261 EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9750CM26A 63228157

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention