BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LVAS MINI APICAL CUFF KIT

    MDR report key: 11235747 · Received January 27, 2021

    Report

    Report Number
    2916596-2021-00352
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Date of Event
    January 19, 2021
    Report Date
    February 4, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013082
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S INVESTIGATION CONCLUSION: ALTHOUGH A SPECIFIC CAUSE FOR THE REPORTED DIFFICULTY IN ENGAGING THE PUMP TO THE MINI APICAL CUFF COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION, THE ACCOUNT COMMUNICATED THAT THE BUILDUP OF SUTURES, PLEDGETS AND MYOCARDIAL TISSUE LIKELY IMPEDED THE CONNECTION OF THE PUMP TO THE MINI APICAL CUFF. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORD FOR THE MINI APICAL CUFF, LOT NUMBER 6859125 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE MINI APICAL CUFF SHIPPED IN THE IMPLANT KIT FOR MLP-020834 ON 11AUG2020. THE HEARTMATE 3 MINI APICAL CUFF KIT INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. IN THE ¿SURGICAL PROCEDURES¿ SECTION, THE IFU EXPLAINS HOW TO PREPARE THE MINI APICAL CUFF AND THE APICAL CUFF HOLDER FOR USE. SECTION ¿DIRECTIONS FOR USE¿ EXPLAINS HOW TO SECURE THE MINI APICAL CUFF TO THE VENTRICLE. THIS SECTION ALSO INSTRUCTS THE USER THAT THE MINI APICAL CUFF SHOULD BE AFFIXED ONLY BY THE SEW-THEN-CUT METHOD AND PLEDGETS SHOULD BE PLACED NO MORE THAN ONE AND A HALF CENTIMETERS FROM THE EDGE OF THE FELT. AFFIXING THE MINI APICAL CUFF USING METHODS OTHER THAN THE PRESCRIBED TECHNIQUE CAN LEAD TO CHALLENGES ENGAGING THE SLIDE LOCK MECHANISM. IN ADDITION, THIS SECTION DESCRIBES HOW TO INSERT THE PUMP INTO THE VENTRICLE. THIS IFU CAUTIONS: *WHEN SEWING THE MINI APICAL CUFF TO THE EXTERIOR OF THE HEART, THE FELT SURFACE SHOULD HAVE A FLAT OR CONVEX SHAPE. THIS IS SO THAT THE PUMP AND SLIDE LOCK MECHANISM CAN ENGAGE THE METAL RING ON THE MINI APICAL CUFF. *THE SUTURE KNOTS SHOULD NOT INTERFERE WITH THE CONNECTION. *IF A SEALING AGENT IS USED ON OR NEAR THE MINI APICAL CUFF, IT SHOULD NOT INTERFERE WITH THE SLIDE LOCK MECHANISM. *IF THE SLIDE LOCK MECHANISM ON THE HEARTMATE 3 LVAD FAILS TO ENGAGE, DO NOT MAKE FURTHER ATTEMPTS TO ENGAGE UNTIL RETRACTING THE SLIDE LOCK MECHANISM. EVIDENCE OF THE SLIDE LOCK MECHANISM FAILING TO ENGAGE WILL BE EITHER VISUAL EVIDENCE OF THE YELLOW ¿WINGS,¿ OR A TACTILE FEEL OF THREE RIDGES VERSUS ONE. THE SLIDE LOCK WILL NOT ENGAGE THE MINI APICAL CUFF UNLESS INITIALLY FULLY RETRACTED. *IF DIFFICULTY PERSISTS WHEN ENGAGING THE SLIDE LOCK MECHANISM, THE LVAD SHOULD BE REMOVED FROM THE MINI APICAL CUFF TO VISUALIZE WHAT MIGHT BE PREVENTING THE CONNECTION. *THE MINI APICAL CUFF MUST BE AFFIXED TO THE LEFT VENTRICLE ONLY BY THE SEW-THEN-CUT METHOD. USING THE CUT-THEN-SEW METHOD MAY LEAD TO CHALLENGES WITH ENGAGING THE SLIDE LOCK MECHANISM. *THE MINI APICAL CUFF MUST BE AFFIXED TO THE LEFT VENTRICLE ONLY BY THE PRESCRIBED TECHNIQUE IN THIS DOCUMENT TO AVOID CHALLENGES WITH ENGAGING THE SLIDE LOCK MECHANISM. *NOTIFY THORATEC PERSONNEL IF THERE IS A CHANGE IN HOW THE DEVICE WORKS, SOUNDS, OR FEELS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) IFU IS ALSO AVAILABLE. THE IFU PROVIDES INSTRUCTIONS ON ALL SURGICAL PROCEDURES, INCLUDING PREPARING THE VENTRICULAR APEX SITE AND INSERTING THE PUMP IN THE VENTRICLE. THE IFU CAUTIONS THAT AFTER THE APICAL CUFF HAS BEEN SEWN TO THE HEART, THE METAL RING ON THE APICAL CUFF SHOULD EXTEND ABOVE THE FELT SURFACE TO ALLOW PROPER ENGAGEMENT AND LOCKING WITH THE SLIDE LOCK OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD). IF THE SLIDE LOCK MECHANISM ON THE HM3 LVAD FAILS TO ENGAGE, DO NOT MAKE FURTHER ATTEMPTS TO ENGAGE UNTIL RETRACTING THE SLIDE LOCK MECHANISM. EVIDENCE OF SLIDE LOCK MECHANISM FAILING TO ENGAGE WILL BE EITHER VISUAL EVIDENCE OF THE YELLOW ¿WINGS¿ OR A TACTILE FEEL OF THREE RIDGES VERSUS ONE. THE SLIDE LOCK WILL NOT ENGAGE THE APICAL CUFF UNLESS INITIALLY FULLY RETRACTED. IF DIFFICULTY PERSISTS WHEN ENGAGING THE SLIDE LOCK MECHANISM, THE LVAD SHOULD BE REMOVED FROM THE APICAL CUFF TO VISUALIZE WHAT MIGHT BE PREVENTING THE CONNECTION. THE SUTURE KNOTS SHOULD NOT INTERFERE WITH THE CONNECTION. IF A SEALING AGENT IS USED ON OR NEAR THE APICAL CUFF, IT SHOULD NOT INTERFERE WITH THE SLIDE LOCK MECHANISM. THE SURGICAL PROCEDURES SECTION ALSO INCLUDES INFORMATION ON DE-AIRING THE PUMP. DURING THE IMPLANT PROCESS, A COMPLETE BACKUP SYSTEM (IMPLANT KIT AND EXTERNAL COMPONENTS) MUST BE AVAILABLE ON-SITE AND IN CLOSE PROXIMITY FOR USE IN AN EMERGENCY. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THIS EVENT.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2021-00351.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ACCOUNT HAD EXTREME DIFFICULTY ATTACHING THE PUMP TO THE MINI APICAL CUFF. THE CASE WAS CONVERTED FROM A THORACOTOMY TO A STERNOTOMY. THIS PROLONGED THE PATIENT'S CARDIOPULMONARY BYPASS TIME. ONCE A STERNOTOMY WAS PERFORMED, THE SURGEON HELPED TO TO CORRECT SOME OF THE TISSUE, SUTURES, AND PLEDGETS THAT MAY HAVE HINDERED THE CONNECTION. THE PUMP WAS THEN ATTACHED TO THE SEWING CUFF. THE PATIENT WAS STABLE IN THE UNIT AND WAS SLOWLY RECOVERING. THE DEVICE PERFORMED AS EXPECTED. THE DIFFICULTY IN ATTACHING THE PUMP TO THE CUFF WAS LIKELY CAUSED BY A BUILDUP OF SUTURES, PLEDGETS, AND MYOCARDIAL TISSUE THAT IMPEDED THE CONNECTION OF THE PUMP TO THE APICAL SEWING CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131292 HEARTMATE 3 LVAS MINI APICAL CUFF KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 10005877 6859125 00813024013082

    Patients

    Seq Age Sex Outcome Treatment
    1 HEARTMATE 3 LVAS IMPLANT KIT