BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS COMMANDER DELIVERY

    MDR report key: 15237787 · Received August 16, 2022

    Report

    Report Number
    2015691-2022-07359
    Event Type
    Malfunction
    Date Received
    August 16, 2022
    Date of Event
    July 5, 2022
    Report Date
    November 8, 2022
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TYPE OF EDWARDS COMMANDER DELIVERY SYSTEM IS UNKNOWN; HOWEVER THESE ARE THE POSSIBLE 510K NUMBER FOR EDWARDS COMMANDER DELIVERY SYSTEM P140031, P200015. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION AND THE FOLLOWING WAS OBSERVED. TEAR AT INFLATION/CRIMP BALLOON BOND. GUIDEWIRE LUMEN AND DISTAL TIP WITH THV WAS DETACHED FROM DELIVERY SYSTEM AND STUCK IN SHEATH SEALS. FLEX SHAFT AND BALLOON SHAFT CUT. BUNCHING OF DELIVERY SYSTEM STRAIN RELIEF. MULTIPLE KINKS ON SEPARATED GUIDEWIRE LUMEN. SHEATH TIP UNOPENED. SHEATH LINER UNEXPANDED. ADHESIVE FOR GUIDEWIRE BOND PRESENT WITHIN THE Y-CONNECTOR. IMAGERY WAS NOT PROVIDED FOR REVIEW. DURING MANUFACTURING, THE DEVICE UNDERGOES MULTIPLE 100% INSPECTIONS. THESE INSPECTIONS AND TESTS DURING THE MANUFACTURING PROCESS SUPPORT THAT IT IS UNLIKELY THAT A NON-CONFORMANCE CONTRIBUTED TO THE REPORTED COMPLAINT. A REVIEW OF THE RISK MANAGEMENT DOCUMENTATION WAS PERFORMED, AND NO EVIDENCE OF PRODUCT NON-CONFORMANCES OR LABELING/IFU INADEQUACIES WERE IDENTIFIED IN THE EVALUATION. THE COMPLAINTS WERE CONFIRMED BASED ON EVALUATION OF THE RETURNED DEVICE. HOWEVER, NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED DURING ENGINEERING EVALUATION. A REVIEW OF THE DHR, LOT HISTORY, MANUFACTURING MITIGATIONS, AND COMPLAINT HISTORY 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. AS REPORTED, ''WHILE ADVANCING THE COMMANDER DELIVERY SYSTEM WITH CRIMPED VALVE THROUGH THE ESHEATH, RESISTANCE WAS ENCOUNTERED. THEREFORE, THE PROCEDURE WAS STOPPED, ALL DEVICES WERE REMOVED WITHOUT CAUSING AN INJURY AND NO CUT DOWN WAS NEEDED.'' ADDITIONALLY, IT WAS REPORTED ''THE DEVICES WERE EVALUATED ON THE BACK TABLE. IT IS THEREFORE POSSIBLE THAT THE COMMANDER'S TIP HAS DETACHED AND THAT IT REMAINED IN THE ESHEATH.'' PRE-DECONTAMINATION EVALUATION OF THE RETURNED DEVICE NOTED A TEAR AT THE INFLATION/CRIMP BALLOON BOND, SEPARATION OF THE GUIDEWIRE LUMEN AND DISTAL TIP WITH CRIMPED THV FROM THE REST OF THE DELIVERY SYSTEM AND STUCK IN THE SHEATH SEALS, AND CLEAN CUTS ON THE BALLOON AND FLEX CATHETERS. IT IS POSSIBLE THAT EXCESSIVE MANIPULATION DURING EVALUATION OF THE DEVICE BY THE FIELD CAUSED THE BALLOON TEAR, DISTAL TIP SEPARATION, AND FLEX SHAFT DAMAGE DURING ATTEMPTS TO REMOVE THE DELIVERY SYSTEM WITH CRIMPED THV FROM THE SHEATH. ADDITIONALLY, IT IS ALSO POSSIBLE THAT THE DELIVERY SYSTEM WITH CRIMPED THV WAS ATTEMPTED TO BE WITHDRAWN THROUGH THE SHEATH SEALS DURING DEVICE REMOVAL. IFU AND INSTRUCTION MANUALS ADVISE TO ''WITHDRAW THE DELIVERY SYSTEM AND SHEATH AS A SINGLE UNIT COMPLETELY'' WHEN THE THV IS STILL CRIMPED ON THE DELIVERY SYSTEM. IF THE DELIVERY SYSTEM WITH CRIMPED THV IS ATTEMPTED TO BE WITHDRAWN THROUGH THE SHEATH, IT MAY BECOME CAUGHT ON THE SHEATH SEALS. EXCESSIVE FORCE APPLIED TO OVERCOME ANY RESISTANCE WITH THE SHEATH SEALS COULD HAVE CAUSED THE BALLOON TEAR, DISTAL TIP SEPARATION, AND FLEX SHAFT DAMAGE OBSERVED. WITHOUT ADDITIONAL INFORMATION, A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED. HOWEVER, AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (EXCESSIVE MANIPULATION) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENTS. 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. NO IFU/LABELING/TRAINING MANUAL INADEQUACIES WERE IDENTIFIED. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTION NOR PRODUCT RISK ASSESSMENT IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED, 23MM SAPIEN 3 ULTRA CASE BY TRANSFEMORAL APPROACH, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE COMMANDER DELIVERY SYSTEM WITH CRIMPED VALVE THROUGH THE ESHEATH. THEREFORE THE PROCEDURE WAS STOPPED AND ALL DEVICES WERE REMOVED WITHOUT CAUSING AN INJURY OR SURGICAL CUT DOWN. NEW DEVICES WERE PREPARED AND THE VALVE WAS SUCCESSFULLY IMPLANTED. THERE WERE NO COMPLICATIONS FOR THE PATIENT AND THE PATIENT WAS DOING WELL POST PROCEDURE. PER PRE-DECONTAMINATION EVALUATION, A VALVE FRAME STRUT WAS SLIGHTLY BENT OUTWARDS AND THE COMMANDER DELIVERY SYSTEM BALLOON TORE AT THE I/C BOND LOCATION, AND THE DISTAL PART WITH VALVE WAS SEPARATED AND REMAINED IN THE ESHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239013 EDWARDS COMMANDER DELIVERY AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9610TF23U 64307253

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Unknown