BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 17149150 · Received June 17, 2023

    Report

    Report Number
    2916596-2023-03469
    Event Type
    Injury
    Date Received
    June 17, 2023
    Date of Event
    May 5, 2022
    Report Date
    March 12, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Removal / Correction Number
    FA-Q124-HF-1
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF AN EXTRINSIC OUTFLOW GRAFT OBSTRUCTION COULD NOT BE CONFIRMED AS NO IMAGES WERE SUBMITTED AND THE DEVICE REMAINS IN USE. FURTHERMORE, THE REPORTED ALARMS COULD NOT BE CONFIRMED AS NO LOG FILES WERE SUBMITTED FOR REVIEW. A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED SHORTNESS OF BREATH AND EDEMA COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 5 OF THE IFU "SURGICAL PROCEDURES" CONTAINS INFORMATION REGARDING THE PREPARATION OF THE SEALED OUTFLOW GRAFT. THIS SECTION INSTRUCTS THE USER TO VERIFY THAT THE GRAFT IS NOT TWISTED OR KINKED BY CHECKING THE POSITION OF THE BLACK LINE ON THE GRAFT ABOVE AND BELOW THE BEND RELIEF AND ENSURING THAT THE LINE IS STRAIGHT. THIS SECTION EXPLAINS THAT WHEN DE-AIRING IS COMPLETED, SLIDE THE BEND RELIEF OVER THE METAL FITTING OF THE SEALED OUTFLOW GRAFT TOWARD THE LOCKING SCREW RING. SECTION 5 OF THE PATIENT HANDBOOK, "ALARMS AND TROUBLESHOOTING", AND SECTION 7 OF THE IFU, "ALARMS AND TROUBLESHOOTING", ADDRESS ALL SYSTEM ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. FURTHERMORE, THE PATIENT HANDBOOK INSTRUCTS THE USER TO CALL THEIR HOSPITAL CONTACT IF THE PATIENT THINKS THAT, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    VOLUNTARY MW NUMBER 3400300000-2022-0000021 WAS RECEIVED 30MAY2023 NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    VOLUNTARY MEDWATCH RECEIVED THAT STATES THE PATIENT COMPLAINED OF VENTRICULAR ASSIST DEVICE ALARMS, SHORTNESS OF BREATH ON EXERTION, AND MILD EDEMA. ON (B)(6) 2023 A RIGHT HEART CATHETERIZATION WAS PERFORMED WITH REDUCED CARDIAC INDEX (1.7) AND INFLOW CANNULA DIRECTED AT POSTURAL WALL. COMPUTERIZED TOMOGRAPHY (CT) PERFORMED WITH NOTED 90 PERCENT OUTFLOW OBSTRUCTION. CT NOTED CIRCUMFERENTIAL THROMBUS OF THE PROXIMAL OUTFLOW CANNULA MEASURING 8.0 CENTIMETERS LENGTH WITH A FOCAL AREA OF NARROWING OVER 90% OCCLUSION. THE PATIENT WAS TAKEN TO SURGERY ON (B)(6) 2023 FOR REMOVAL OF THE BEND RELIEF AND THE PRESSURIZED PROTEINACEOUS JELLY THAT WAS COMPRESSING THE GRAFT. IMMEDIATE CESSATION OF PUMP ALARMS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458355 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7066575 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention| H