BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 11253468 · Received January 29, 2021

    Report

    Report Number
    2916596-2021-00516
    Event Type
    Malfunction
    Date Received
    January 29, 2021
    Date of Event
    January 25, 2021
    Report Date
    February 15, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF DAMAGE TO THE PATIENT'S DRIVELINE CAN BE CONFIRMED BASED ON THE EVALUATION OF THE SUBMITTED PHOTOS. A DIRECT CORRELATION BETWEEN HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED ANEMIA COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE ACCOUNT COMMUNICATED THAT A COSMETIC TEAR WAS NOTED TO THE PATIENT¿S DRIVELINE. ACCORDING TO THE ACCOUNT, THE DRIVELINE WAS REPAIRED WITH TAPE. THE DRESSING WAS REMOVED, AND DAMAGED PORTION OF THE DRIVELINE WAS VISUALIZED. SILICONE WAS INJECTED INTO THE DAMAGED PORTION WITH A BLUNT TIPPED SYRINGE. THE SILICONE WAS THEN SPREAD DISTALLY ACROSS THE EXTERIOR PORTION WHERE THE DRIVELINE DAMAGE WAS NOTED. TEFLON TAPE WAS THEN COMPLETELY WRAPPED OVER THE SILICONE-REPAIRED AREAS, WITH NO VISIBLE AREAS OF DAMAGE OR SILICONE NOTED AFTERWARDS. THE DRIVELINE DRESSING WAS THEN REPLACED. THE ACCOUNT COMMUNICATED THAT AN ESOPHAGOGASTRODUODENOSCOPY (EGD) AND COLONOSCOPY WAS PERFORMED WITH NO INTERVENTION. ACCORDING TO THE ACCOUNT, THE PATIENT WAS ALSO ADMITTED FOR ANEMIA AND WAS RESTARTED ON COUMADIN. THE ACCOUNT COMMUNICATED THAT ONCE THE PATIENT¿S INR IS THERAPEUTIC THE PATIENT WILL BE DISCHARGED. REPORTEDLY, THE DEVICE OPERATING AS EXPECTED. THE PATIENT REMAINS ONGOING ON HEARTMATE II LVAS, SERIAL NUMBER (B)(6). HEARTMATE II LVAS PATIENT HANDBOOK, IS CURRENTLY AVAILABLE. SECTION 4 OF THIS HANDBOOK CONTAINS A SECTION ON ¿CARING FOR THE DRIVELINE;" HOWEVER, ALL HEARTMATE II LVAD DRIVELINES HAVE THE POTENTIAL FOR WIRE/SHIELD BREAKDOWN TO OCCUR DEPENDENT UPON LENGTH OF USE AND MOVEMENT/FLEXING OVER TIME. ADDITIONALLY, THE HEARTMATE II LVAS INSTRUCTIONS FOR USE (FU), IS ALSO AVAILABLE. THIS IFU LISTS BLEEDING AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. THE SECTION ENTITLED ¿ONGOING PATIENT ASSESSMENT AND CARE¿ PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING RECOMMENDED INR VALUES, AND THE SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THAT THERE IS A RISK OF BLEEDING. THE SECTION "SYSTEM OPERATIONS" DESCRIBES THE "DRIVELINE" AND OUTLINES INDICATIONS OF DRIVELINE DAMAGE AS WELL AS HOW TO RESPOND TO SUCH EVENTS. THE SECTION "EQUIPMENT STORAGE AND CARE" DESCRIBES "CARE OF THE DRIVELINE." THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT SHIPPED ON 24JUL2017. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A COSMETIC TEAR IN THE DRIVELINE. IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF REPEATED REPAIRS WITH RESCUE TAPE THAT DID NOT WORK. THE CENTER REQUESTED FURTHER OPTIONS FOR REPAIRING THE SILICONE. IT WAS RECOMMENDED TO USE SILICONE ADHESIVE WITH PLUMBERS TAPE TO ALLOW THE ADHESIVE TO CURE. THE CENTER DISCUSSED WITH TECH SERVICES ABOUT THE APPROPRIATE INTERVENTION. THE DRESSING WAS REMOVED AND DAMAGED PORTION OF THE DRIVELINE WAS VISUALIZED. SILICONE WAS INJECTED INTO THE DAMAGED PORTION WITH A BLUNT TIPPED SYRINGE. THE SILICONE WAS THEN SPREAD DISTALLY ACROSS THE EXTERIOR PORTION WHERE THE DRIVELINE DAMAGE WAS NOTED. TEFLON TAPE WAS THEN COMPLETELY WRAPPED OVER THE SILICONE-REPAIRED AREAS, WITH NO VISIBLE AREAS OF DAMAGE OR SILICONE NOTED AFTERWARDS. THE DRIVELINE DRESSING WAS THEN REPLACED BY THE NP. NP WAS INSTRUCTED BY CLINICAL SPECIALIST LEAVE THE TEFLON TAPE ON FOR AT LEAST SEVENTY-TWO HOURS PRIOR TO REMOVAL. DURING THE ENTIRETY OF THE PROCEDURE THE PUMP AND ITS COMPONENTS CONTINUED TO FUNCTION AS INTENDED WITH NO NOTED ALARMS. THE PATIENT REMAINED CLINICALLY STABLE WITHOUT ANY COMPLAINT OF PAIN OR DISCOMFORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147807 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 6073401 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR