BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 16853772 · Received May 2, 2023

    Report

    Report Number
    2916596-2023-02374
    Event Type
    Injury
    Date Received
    May 2, 2023
    Date of Event
    April 12, 2023
    Report Date
    June 13, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF OUTFLOW GRAFT DAMAGE RESULTING IN BLOOD LEAKAGE COULD NOT BE CONFIRMED AS NO IMAGES WERE SUBMITTED FOR REVIEW AND THE DEVICE REMAINS IN USE. ALTHOUGH A SPECIFIC CAUSE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION, THE ACCOUNT INDICATED THAT THE DAMAGE MAY HAVE BEEN A RESULT OF MECHANICAL STRESS DURING A SURGICAL PROCEDURE. ADDITIONALLY, A DIRECT CORRELATION BETWEEN THE HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER: (B)(6), AND THE REPORTED EVENTS OF CHEST WALL BLEEDING AND INFECTION COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON THE HM3 LVAS, SERIAL NUMBER: (B)(6), WITH NO FURTHER ISSUES REPORTED AT THIS TIME. NO PRODUCT IS AVAILABLE FOR INVESTIGATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6), AS WELL AS THE SEALED OUTFLOW GRAFT, LOT NUMBER: 7871298, 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 HM 3 PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1 OF THIS IFU, ¿INTRODUCTION¿, LISTS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HM 3 LVAS, INCLUDING BLEEDING, AND INFECTION (LOCAL, DRIVELINE, AND PUMP POCKET). SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿ANTICOAGULATION¿), PROVIDES INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION REGIMEN, INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) VALUES, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THERE IS A RISK OF BLEEDING. SECTION 6 OF THE IFU, ¿PATIENT CARE AND MANAGEMENT¿, ALSO LISTS INFECTION AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. FURTHERMORE, SEVERAL SECTIONS OF THE IFU AND PATIENT HANDBOOK PROVIDE CARE INSTRUCTIONS REGARDING HOW TO PREVENT INFECTION AS WELL AS SUGGESTED RESPONSES IN THE EVENT OF INFECTION. THE IFU PROVIDES INFORMATION REGARDING HOW TO PREPARE THE SEALED OUTFLOW GRAFT FOR IMPLANT AND INCLUDES STEPS FOR ATTACHING THE OUTFLOW GRAFT TO THE PUMP. THE IFU WARNS THAT FAILURE TO CONNECT THE BEND RELIEF SO THAT IT IS FULLY AND EVENLY CONNECTED CAN ALLOW KINKING AND ABRASION OF THE GRAFT, WHICH MAY LEAD TO SERIOUS ADVERSE EVENTS SUCH AS LOW LEFT VENTRICULAR ASSIST DEVICE FLOW AND/OR BLEEDING. THE IFU ALSO INSTRUCTS THE USER TO VISUALLY INSPECT THE BEND RELIEF TO CONFIRM THAT IT IS FULLY CONNECTED AND SEATED TO THE SEALED OUTFLOW GRAFT. TO CONFIRM, TRY TO UNSEAT THE CONNECTED BEND RELIEF FROM THE METAL FITTING BY GENTLY PULLING THE BEND RELIEF BACK TOWARD THE ANASTOMOSIS AND THEN TOWARDS THE PUMP. THE BEND RELIEF SHOULD REMAIN CAPTURED AND MOVE APPROXIMATELY 0.5 MM WITHOUT DISENGAGING FROM THE GRAFT. THE IFU AND PATIENT HANDBOOK ADDRESS ALL SYSTEM ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. THESE DOCUMENTS ALSO PROVIDE EXAMPLES OF EMERGENCIES AND THE PROPER ACTIONS TO TAKE IN THE EVENT AN EMERGENCY OCCURS. QAP, OUTFLOW ASSEMBLY, HM 3 DESCRIBES THE INSPECTION STEPS AND THE ACCEPTANCE CRITERIA FOR THE HEARTMATE 3 OUTFLOW ASSEMBLY. SECTION 8.4.7 DESCRIBES THE VISUAL INSPECTION OF THE GRAFT-TO-HARDWARE INTERFACE. SECTION 8.4.8 DESCRIBES THE INSPECTION AND ACCEPTANCE CRITERIA OF THE GRAFT IN RELATION TO DAMAGE AND SOILING. THE GRAFT IS CONSIDERED ACCEPTABLE IF IT IS FREE FROM DAMAGE OF WRINKLES, CREASES, OR UNACCEPTABLE SOILING. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD BLEEDING FROM THE CHEST WALL FROM THE TISSUES OF THE FISTULA. BLOOD PRODUCTS WERE GIVEN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE LESION WAS DISTAL TO THE BEND RELIEF. IT WAS HYPOTHESIZED THAT THE DAMAGE RESULTED FROM MECHANICAL STRESS DURING THE BANDAGE CHANGE PROCEDURE AT THE DESIGNATED PLACE OF RESIDENCE. THE DAMAGE WAS REPAIRED WITH SURGICAL SUTURES THAT WERE SKILLFULLY EMPLOYED. THE DAMAGE AND BLEEDING RESOLVED AFTER OPERATION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT A CARDIAC COMPUTED TOMOGRAPHY (CT) WAS PERFORMED. THE PATIENT HAD A CRITICAL HEMORRHAGE EMANATING FROM A FISTULA LOCATED IN THE REGION OF THE XIPHOID PROCESS, WHICH WAS THE RESULT OF A DECOMPENSATED DEEP-LAYER INFECTION. DURING THE SURGICAL PROCEDURE, A LESION WAS INCIDENTALLY IDENTIFIED IN THE OUTFLOW GRAFT OF THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) THAT WAS DETERMINED TO BE THE SOURCE OF THE BLEEDING. THE BLEEDING RESOLVED AFTER OPERATION. THE PATIENT WAS ON THE URGENT WAITING LIST, AND A RECURRENCE OF BLEEDING WOULD NECESSITATE PURSUING A TRANSPLANTATION PROCEDURE AS A VIABLE SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152333 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 7929442

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Required Intervention| H