BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 14219633 · Received April 27, 2022

    Report

    Report Number
    2916596-2022-10392
    Event Type
    Injury
    Date Received
    April 27, 2022
    Date of Event
    April 4, 2022
    Report Date
    June 29, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENT COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. FURTHERMORE, A SPECIFIC CAUSE FOR THE PATIENT'S INFECTION COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6). 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 10FEB2022. REVIEW OF THE STERILIZATION AND PACKAGING DOCUMENTATION IN THE DEVICE HISTORY RECORDS FOUND NO DEVIATIONS FROM MANUFACTURING SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTION FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1 OF THIS DOCUMENT LISTS HEPATIC DYSFUNCTION AND INFECTION AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ (UNDER "ANTICOAGULATION") 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. CARE INSTRUCTIONS IN REGARD TO PREVENTING INFECTION ARE PROVIDED IN VARIOUS SECTIONS OF THE IFU, INCLUDING CONTROLLING INFECTION. THE HEARTMATE 3 LVAS PATIENT HANDBOOK IS ALSO CURRENTLY AVAILABLE. THIS DOCUMENT CONTAINS INFORMATION ABOUT 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 ELEVATED ASPARTATE AMINOTRANSFERASE (AST) AND WHITE BLOOD CELL (WBC) LEVELS, AS WELL AS A DECREASED PLATELET COUNT POST-IMPLANT. PLEURAL EFFUSION WAS SUSPECTED BASED ON LEFT BASILAR OPACITY. THE PATIENT WAS ONGOING AND IN A STABLE CONDITION. THE PATIENT WAS ALSO ANEMIC, WITH BASELINE HEMOGLOBIN OF 13.1 ON (B)(6) 2022 10.5, 11.3 ON (B)(6) 2022 10.6, (B)(6) 2022 10.3, 10.3,10.2, (B)(6) 2022 9.7. LEUKOCYTOSIS BLOOD CULTURED WERE NEGATIVE TO DATE. THE PATIENT LATER EXPERIENCED UP TRENDING PLATELET COUNT, BASELINE OF 148, ON (B)(6) 2022 329, ON (B)(6) 2022 377, ON (B)(6) 2022 438, ON (B)(6)2022 498, ON (B)(6) 2022 581, ON (B)(6) 2022 701. ON (B)(6) 2022, ID CONSULTED FOR AFEBRILE LEUKOCYTOSIS, COMPUTERIZED TOMOGRAPHY (CT) ON THE CHEST/SINUSES WAS REVIEWED AND ONLY SMALL-TO-MODERATE PLEURAL EFFUSION PRESENT ON LAST CXR. ON (B)(6) 2022 IT WAS DETERMINED THAT THERE WAS NO EVIDENCE OF UNTREATED INFECTION AND THE PATIENT WAS SET TO BE MONITORED OFF OF ANTIBIOTICS.

    Description of Event or Problem · 0

    THE PATIENT EXPERIENCED THROMBOCYTOPENIA AND ANEMIA ON (B)(6) 2022. THE PATIENT EXPERIENCED THROMBOCYTOSIS ON (B)(6) 2022. THE PATIENT WAS COVID-19 POSITIVE ON (B)(6) 2022. THE HEPATIC DYSFUNCTION THE PATIENT WAS EXPERIENCING WAS NOT THOUGHT TO BE DEVICE RELATED. THE PATIENT'S HEPATIC DYSFUNCTION RESOLVED WITHOUT SEQUELAE ON (B)(6) 2022. THE PATIENT WAS DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1636431 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 8325426 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Other| R| H