BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 16714189 · Received April 11, 2023

    Report

    Report Number
    2916596-2023-01900
    Event Type
    Injury
    Date Received
    April 11, 2023
    Date of Event
    March 23, 2023
    Report Date
    July 11, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE EVALUATION OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, SERIAL NUMBER (B)(6), DID NOT REVEAL ANY DEVICE-RELATED ISSUES. A DIRECT CORRELATION BETWEEN (B)(6) AND THE PATIENT'S OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. (B)(6) WAS RETURNED ASSEMBLED WITH THE PUMP CABLE INTACT. THE MODULAR CABLE WAS ALSO RETURNED WITH THE DEVICE (REFER TO PI MAIN # PI-2023-0051315-02 FOR EVALUATION OF THE MODULAR CABLE). THE SEALED OUTFLOW GRAFT WAS SECURED TO THE PUMP COVER OUTLET PORT. THE OUTFLOW GRAFT BEND RELIEF WAS ATTACHED AT THE GRAFT HARDWARE. THE APICAL CUFF WAS RETURNED WITH THE CUFF LOCK FULLY ENGAGED AND INCLUDED A SECTION OF TISSUE FROM THE VENTRICLE. EXAMINATION OF THE BLOOD-CONTACTING SURFACES OF THE DEVICE DID NOT REVEAL ANY DEVELOPED DEPOSITIONS OR THROMBUS FORMATIONS THAT WOULD HAVE CONTRIBUTED TO A FLOW OR FUNCTIONAL ISSUE. VISUAL INSPECTION OF THE PUMP ROTOR AND ROTOR WELL DID NOT REVEAL ANY OBVIOUS SURFACE SCRATCHES OR DEFECTS. THE LEFT VENTRICULAR ASSIST DEVICE LOG FILES RETRIEVED FROM THE RETURNED DEVICE APPEARED TO CAPTURE THE PUMP FUNCTIONING AS INTENDED. (B)(6) WAS CLEANED, REBUILT, AND FUNCTIONALLY TESTED ON A MOCK CIRCULATORY LOOP. THE DEVICE OPERATED AS INTENDED AND IN ACCORDANCE WITH MANUFACTURING SPECIFICATIONS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATION FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE (REV. G) CONTAINS THE FOLLOWING INFORMATION: SECTION 1 LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, INCLUDING DEATH. SECTION 5 CAUTIONS THE USER THAT SHARP BENDS, TWISTS, OR KINKS IN THE DRIVELINE MAY MAKE IT MORE SUSCEPTIBLE TO WEAR AND FATIGUE OVER TIME. SECTION 6 CAUTIONS THE USER TO AVOID PULLING ON OR MOVING THE DRIVELINE. THIS SECTION FURTHER CAUTIONS: "DO NOT TWIST, KINK, OR SHARPLY BEND THE DRIVELINE, SYSTEM CONTROLLER POWER CABLES, THE POWER MODULE PATIENT CABLE, OR THE MOBILE POWER UNIT PATIENT CABLE, WHICH MAY CAUSE DAMAGE TO THE WIRES INSIDE, EVEN IF EXTERNAL DAMAGE IS NOT VISIBLE. DAMAGE TO THE DRIVELINE OR CABLES COULD CAUSE THE LEFT VENTRICULAR ASSIST DEVICE TO STOP. IF THE DRIVELINE OR CABLES BECOME TWISTED, KINKED, OR BENT, CAREFULLY UNRAVEL AND STRAIGHTEN. SECTION 6 ALSO INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS AND TO COUNSEL PATIENTS TO INFORM THEIR HOSPITAL CONTACT IMMEDIATELY IF THEY FIND SIGNS OF DRIVELINE DAMAGE. SECTION 7 PROVIDES ADDITIONAL INSTRUCTIONS REGARDING DRIVELINE CARE. SECTION 8 STATES: "AS NEEDED, CLEAN EXTERIOR SURFACES OF THE DRIVELINE CABLES WITH A DAMP, LINT-FREE CLOTH. IF MORE AGGRESSIVE CLEANING IS NEEDED, USE WARM WATER AND MILD DISH SOAP." THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM PATIENT HANDBOOK, REV. G, CONTAINS THE FOLLOWING INFORMATION: SECTION 4 CONTAINS INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE. THIS SECTION INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE AND TO CALL YOUR HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED. SECTION 4 ALSO INSTRUCTS THE USER TO KEEP THE DRIVELINE CLEAN. WIPE OFF ANY DIRT OR GRIME. IF THE DRIVELINE GETS DIRTY, USE A TOWEL WITH MILD DISH SOAP AND WARM WATER TO GENTLY CLEAN IT. NEVER SUBMERGE THE DRIVELINE OR OTHER SYSTEM COMPONENTS IN WATER OR LIQUID. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED. (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE DEATH WAS NO THOUGHT TO BE DEVICE OR THERAPY RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1720971 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 6489676

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death