BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 14635428 · Received June 8, 2022

    Report

    Report Number
    2916596-2022-11308
    Event Type
    Injury
    Date Received
    June 8, 2022
    Date of Event
    December 31, 2020
    Report Date
    July 20, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEVICE WAS IMPLANTED AT THE TIME OF THE EVENT. AUTHOR INFORMATION: P. ROSE, ET AL. ADVERSE EVENTS IN HVAD VS. HM3 PATIENTS UNDER OUTPATIENT BRIDGING WITH LOW-MOLECULAR WEIGHT HEPARIN FOR SUBTHERAPEUTIC ANTICOAGULATION, THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, VOL 41, NO 4S, APRIL 2022. DEPARTMENT OF HEART SURGERY, UNIVERSITY HOSPITAL HEIDELBERG, HEIDELBERG, GERMANY. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED BLEEDING, GASTROINTESTINAL BLEEDING, ISCHEMIC STROKE, HEMORRHAGIC STROKE, AND SUSPECTED THROMBUS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE HEARTMATE 3 DEVICE SERIAL NUMBERS AND OTHER SPECIFIC CASE/PATIENT INFORMATION IS NOT AVAILABLE. NO PRODUCT WAS EVALUATED UNDER THIS COMPLAINT. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU) (REV. G) IS CURRENTLY AVAILABLE. THE HEARTMATE 3 LVAS IFU LISTS BLEEDING, STROKE, AND PUMP THROMBOSIS AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THE IFU ALSO PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING THE RECOMMENDED INR (INTERNATIONAL NORMALIZED RATIO) VALUES. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    DATE OF EVENT IS APPROXIMATE AS THE DATA WAS COLLECTED BETWEEN JANUARY 2015 AND DECEMBER 2020. IT WAS REPORTED THROUGH THE RESEARCH ARTICLE "ADVERSE EVENTS IN HVAD VS. HM3 PATIENTS UNDER OUTPATIENT BRIDGING WITH LOW-MOLECULAR WEIGHT HEPARIN FOR SUBTHERAPEUTIC ANTICOAGULATION" THAT HEARTMATE 3 (HM3) MAY BE ASSOCIATED WITH BLEEDING, NEUROLOGICAL EVENTS, AND DEATH. THIS SINGLE-CENTER RETROSPECTIVE STUDY EVALUATED 30 PATIENTS IMPLANTED WITH HM3 BETWEEN JAN 2015 AND DEC 2020. PATIENTS WERE FOLLOWED UP FROM INITIAL DISCHARGE AFTER HM3 IMPLANTATION UNTIL DEATH, HEART TRANSPLANTATION OR END OF THE OBSERVATION PERIOD, SEP 2021. BRIDGING FOR SUBTHERAPEUTIC INTERNATIONAL NORMALIZED RATIO (INR) (= 0.4 BELOW TARGET INR) WERE PROVIDED WITH ENOXAPARIN IN A THERAPEUTIC DOSE ADAPTED TO WEIGHT AND RENAL FUNCTION. ONLY PATIENTS WITH AN INR > 0.4 BELOW TARGET INR WERE ADMITTED TO HOSPITAL FOR BRIDGING WITH INTRAVENOUS UNFRACTIONATED HEPARIN. BLEEDING EVENTS LEADING TO HOSPITAL ADMISSION AND CEREBROVASCULAR EVENTS WERE EVALUATED AND PROVIDED IN PERCENT OF STUDY POPULATION AND/OR EVENTS PER PATIENT YEAR (EPPY). THE OVERALL MORTALITY WAS 18.2%. BLEEDING EVENTS OCCURRED IN 42.7% OF PATIENTS, WITH GASTROINTESTINAL (GI) BLEEDING OCCURRING IN 21.8% OF PATIENTS (0.05 EPPY). STROKE, TRANSIENT ISCHEMIC ATTACK (TIA) AND PROLONGED REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT (PRIND) OCCURRED IN 5.5% OF PATIENTS (0.01 EPPY). INTRACEREBRAL HEMORRHAGE HAD AN OVERALL 0.04 EPPY. RELATED DEATH MFR #: 2916596-2022-11307.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2289319 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| H