BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U

    MDR report key: 10453907 · Received August 26, 2020

    Report

    Report Number
    2015691-2020-13303
    Event Type
    Death
    Date Received
    August 26, 2020
    Date of Event
    August 4, 2020
    Report Date
    August 4, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMMANDER DELIVERY SYSTEM WAS RETURNED IN THE UNLOCK POSITION WITH ALMOST FULL FINE ADJUST AND NO FLEX USED. THE DELIVERY SYSTEM WAS FULLY INSERTED THROUGH THE LOADER ASSEMBLY AND GUIDEWIRE. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED A SLIGHT KINK ON THE NOSE TOP. X-RAYS OF THE HANDLE AND FLEX TIP NOTED NO ABNORMALITIES. FUNCTIONAL TESTING OF THE RETURNED DEVICE FOUND THE FLEX WHEEL OF DELIVERY SYSTEM WAS ABLE TO BE FULLY FLEXED WITHOUT ANY ISSUE. THE ENTIRE ARTICULATION TRAVEL WAS ABLE TO BE ACHIEVED WITHOUT ANY RESISTANCE OBSERVED. THE IMAGERY PROVIDED BY SITE SHOWS THE PATIENT CONDITIONS. THERE IS TORTUOSITY AND CALCIFICATION PRESENT IN THE PATIENT¿S ACCESS VESSEL. THERE IS A SIGNIFICANT BEND NOTED IN THE DESCENDING AORTA AND IS HORIZONTAL. A DEVICE HISTORY RECORD (DHR) REVIEW DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE LOT HISTORY REVEALED NO OTHER SIMILAR COMPLAINTS. THE INSTRUCTIONS FOR USE (IFU), DEVICE PREPARATION AND THE TRAINING MANUAL WERE REVIEWED FOR INSTRUCTIONS OR GUIDANCE FOR PROPER USE OF THE COMMANDER DELIVERY SYSTEM AND NO DEFICIENCIES WERE IDENTIFIED. DURING THE MANUFACTURING PROCESS, THE COMMANDER IS VISUALLY INSPECTED AND TESTED SEVERAL TIMES. DURING MANUFACTURING, THE DEVICE WAS 100% INSPECTED. DURING THE FINAL INSPECTION, THE DEVICE UNDERWENT 100% INSPECTION BY BOTH MANUFACTURING AND QUALITY. ADDITIONALLY, ALL MANUFACTURING LOTS ARE SUBJECT TO PRODUCT VERIFICATION (PV) TESTING ON A SAMPLING BASIS. ALL SAMPLES PASSED PRODUCT VERIFICATION TESTING FOR THIS LOT NUMBER. THESE INSPECTIONS AND TESTS DURING THE MANUFACTURING PROCESS SUPPORT THAT IT IS UNLIKELY THAT A NON-CONFORMANCE CONTRIBUTED TO THE REPORTED EVENT.   PER THE INSTRUCTIONS FOR USE (IFU) CARDIOVASCULAR INJURY, SUCH AS PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TAVR PROCEDURE. AN AORTIC DISSECTION MAY OCCUR WHEN MULTIPLE ATTEMPTS ARE MADE TO CROSS THE STENOTIC NATIVE VALVE, AND/OR WHEN EXCESSIVE FORCE IS USED.  PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE (THV). THE THV TRAINING MANUALS PROVIDE GUIDANCE TO FACILITATE SAFE CROSSING OF THE NATIVE VALVE, INCLUDING CAMERA PROJECTIONS, HANDLING DURING ADVANCEMENT, AND TROUBLESHOOTING TECHNIQUES IF DIFFICULTY IS ENCOUNTERED. AS STATED, EXCESSIVE FORCE SHOULD NOT BE USED WHEN THE DEVICE HAS DIFFICULTY CROSSING THE STENOTIC VALVE. ADDING TENSION TO THE WIRE, PULLING BACK THE SYSTEM TO RE-ORIENT THE VALVE, AS NEEDED, AND TORQUEING OF THE FLEX CATHETER MAY BE HELPFUL IN SOLVING THE PROBLEM. 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 FOR DELIVERY SYSTEM TRACKING DIFFICULTY WAS UNABLE TO BE CONFIRMED DUE TO THE UNAVAILABILITY OF APPLICABLE IMAGERY. HOWEVER, NO MANUFACTURING NONCONFORMANCE WAS IDENTIFIED DURING THE EVALUATION. THE RETURNED DEVICE WAS FUNCTIONALLY TESTED AND FULL FLEX WAS ACHIEVED WITHOUT ANY RESISTANCE OBSERVED. A REVIEW OF THE DHR, LOT HISTORY, AND MANUFACTURING MITIGATIONS DID NOT PROVIDE ANY INDICATION THAT A MANUFACTURING NON-CONFORMANCE WOULD HAVE CONTRIBUTED TO THE COMPLAINT. A REVIEW OF THE IFU AND TRAINING MANUALS REVEALED NO DEFICIENCIES. IT CAN BE NOTED IN THE PROVIDE 3MENSIO, THE PATIENT HAD TORTUOSITY PRESENT WITH A SIGNIFICANT BEND IN THE DESCENDING AORTA. ADDITIONALLY, AS REPORTED, ¿THE SUPERVISING PHYSICIAN AND FCS BELIEVE THE EVENT WAS DUE TO PATIENT FACTORS OF TORTUOSITY AND THE HORIZONTAL AORTA.¿ AS SUCH IT IS POSSIBLE THAT DELIVERY SYSTEM WAS UNABLE TO BE ADVANCED THROUGH THE PATIENT ANATOMY DUE TO THE PRESENT TORTUOSITY, AS TORTUOSITY CAN CREATE CHALLENGING PATHWAYS FOR THE DELIVERY SYSTEM TO HAVE TO TRACK THROUGH, LEADING TO THE REPORTED EVENT. AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (TORTUOUS ANATOMY) LIKELY CONTRIBUTED TO THE EVENTS. 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 COMPLAINT FOR DIFFICULTY ADVANCING THE DELIVERY SYSTEM RESULTING IN AORTIC DISSECTION WAS UNABLE TO BE CONFIRMED DUE TO UNAVAILABILITY OF APPLICABLE IMAGERY. NO MANUFACTURING NONCONFORMANCE WAS IDENTIFIED DURING THE EVALUATION. NO LABELING/IFU/TRAINING INADEQUACIES WERE IDENTIFIED. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT ESCALATION, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). THE INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    AS REPORTED VIA THE FIELD CLINICAL SPECIALIST, DURING THE PROCEDURE OF A 26 MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH THE PATIENT WAS OBSERVED TO HAVE SEVERE TORTUOSITY AND A HORIZONTAL AORTA. A LUNDERQUIST WIRE WAS USED, HOWEVER THE LEFT VENTRICLE WAS OBSERVED TO BE SMALL AND WITH THE HORIZONTAL AORTA THERE WAS CONCERN OF A PERFORATION. THE LUNDERQUIST WIRE WAS SWITCHED OUT FOR A SAFARI WIRE. THERE WAS NO DIFFICULTY INSERTING THE SHEATH INTO THE PATIENT. THERE WAS NO DIFFICULTY PASSING THE DELIVERY SYSTEM AND VALVE THROUGH THE SHEATH. WHEN THE DELIVERY SYSTEM AND VALVE PASSED THE SHEATH AND ENTERED THE AORTIC ARCH THE FELLOW STATED SHE FELT "SOME RESISTANCE." IT WAS UNABLE TO BE CONFIRMED IF THIS AREA HAD SIGNIFICANT TORTUOSITY. THE FELLOW CONTINUED AND THE PATIENT¿S PRESSURE BEGAN TO DROP. IMAGING SHOWED THE NOSE CONE HAD PERFORATED THE AORTA. THE VALVE WAS DEPLOYED SUCCESSFULLY IN THE DESCENDING AORTA AND THE DELIVERY SYSTEM WAS WITHDRAWN WITH NO RESISTANCE. UPON REMOVAL THERE WAS NO DAMAGE NOTED TO EITHER THE DELIVERY SYSTEM OR THE SHEATH. A STENT WAS PLACED IN THE AORTA AT THE PERFORATION, HOWEVER THE PATIENT CONTINUED TO DECOMPENSATE AND EXPIRED SAME DAY. WHILE THE FELLOW MENTIONED THERE WAS RESISTANCE BOTH THE SUPERVISING PHYSICIAN AND FCS BELIEVE THE EVENT WAS DUE TO PATIENT FACTORS OF TORTUOSITY AND THE HORIZONTAL AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920920 EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9750CM26A 63237841

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death| R