BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 15620683 · Received October 17, 2022

    Report

    Report Number
    2916596-2022-14304
    Event Type
    Death
    Date Received
    October 17, 2022
    Date of Event
    May 30, 2021
    Report Date
    November 11, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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: A DIRECT CORRELATION BETWEEN HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER: (B)(6), AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, A SPECIFIC CAUSE FOR THE PATIENT¿S SEPSIS AND INFECTION COULD NOT BE DETERMINED. HEARTMATE 3 LVAS, SERIAL NUMBER: (B)(6), WAS NOT EXPLANTED FOR 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 IMPLANT KIT WAS SHIPPED ON 01NOV201. REVIEW OF THE STERILIZATION AND PACKAGING DOCUMENTATION IN THE DEVICE HISTORY RECORDS FOUND NO DEVIATIONS FROM MANUFACTURING SPECIFICATIONS. THE HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) AND THE HM3 LVAS PATIENT HANDBOOK (PHB) ARE BOTH CURRENTLY AVAILABLE. THE HM3 LVAS INSTRUCTIONS FOR USE (IFU) LISTS POTENTIAL ADVERSE EVENTS SUCH AS RENAL DYSFUNCTION, BLEEDING, SEPSIS, VARIOUS TYPES OF INFECTION, AND DEATH AND OUTLINES THE RECOMMENDED ANTICOAGULATION THERAPY AND INTERNATIONAL NORMALIZED RATIO (INR) RANGE. SECTION 6 OF THE HM3 IFU OUTLINES THE RECOMMENDED ANTICOAGULATION REGIMEN (INCLUDING INTERNATIONAL NORMALIZED RATIO (INR) RANGE FOR PATIENTS USING THE HEARTMATE 3 LVAS AS WELL AS THE SUGGESTED ANTICOAGULATION MODIFICATIONS IN THE EVENT THAT THERE IS A RISK OF BLEEDING. SEVERAL SECTIONS OF THE PHB ALSO PROVIDE CARE INSTRUCTIONS IN REGARDS TO PREVENTING INFECTION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED ACUTE KIDNEY INJURY (AKI) ON (B)(6) 2021. THE PATIENT WAS ADMITTED AND THE GASTROINTESTINAL (GI) DEPARTMENT CONSULTED. THE PATIENT WAS TRANSFUSED FOR DROPPING HEMOGLOBIN AND UNDERWENT AN ESOPHAGOGASTRODUODENOSCOPY (EGD)/COLONOSCOPY WITH GI AND AN INFLAMMATORY POLYP WAS REMOVED. HEMOGLOBIN WAS DOWN TRENDING AND GI WAS CONSULTED AGAIN. A CAPSULE STUDY SHOWED NO BLEEDING. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS AND UNDERWENT CHEST WALL DEBRIDEMENT/MEDIASTINAL EXPLORATION FOR A CHEST WALL ABSCESS. RENAL REPLACEMENT THERAPY CALLED FOR ALTERED MENTAL STATUS/LETHARGY AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR OPTIMAL FLOW. AFTER FAMILY DISCUSSIONS, IT WAS DECIDED TO MOVE TO COMFORT CARE TO ALIGN WITH PATIENT WISHES. THE PATIENT ULTIMATELY EXPIRED ON (B)(6) 2021 AT 14:58 DUE TO AKI, GI BLEED, ACUTE RHEUMATIC FEVER, AND SEPSIS. THE DEVICE WAS NOT EXPLANTED AND WOULD NOT BE RETURNED FOR EVALUATION. THE DEATH WAS NOT CONSIDERED DEVICE OR THERAPY RELATED AND THE DEVICE OPERATED AS EXPECTED. THE AKI WAS NOT DETERMINED TO BE RELATED TO OR CAUSED BY THE DEVICE OR THERAPY RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2307694 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 6192560 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Life Threatening| D