BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 12395241 · Received August 31, 2021

    Report

    Report Number
    2916596-2021-04934
    Event Type
    Injury
    Date Received
    August 31, 2021
    Date of Event
    May 17, 2021
    Report Date
    October 28, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT¿S HEALTHCARE PROVIDERS STATED THAT THE EPISTAXIS WAS CAUSED BY A SEPTAL DEFECT WITH SUSPECTED GRANULOMATOSIS WITH POLYANGIITIS. THESE CONDITIONS ARE EXCLUSIVELY RELATED TO THE PATIENT'S PHYSIOLOGICAL CONDITION ARE NOT RELATED TO THE USE OF THE DEVICE OR A DEVICE MALFUNCTION. THEREFORE THIS EVENT DOES NOT MEET REPORTING REQUIREMENTS AND WAS DOWNGRADED BY THE MANUFACTURER. MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED BILATERAL EPISTAXIS, AS WELL AS A DIRECT CORRELATION TO THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER MLP-021828, COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER (B)(6). NO PRODUCT IS AVAILABLE FOR INVESTIGATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE LVAS KIT WAS SHIPPED ON (B)(6) 2020. THE HEARTMATE 3 LVAS IFU AND PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. THIS IFU LISTS BLEEDING AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM IN SECTION 1, ¿INTRODUCTION¿. SECTION 6, ¿PATIENT CARE AND MANAGEMENT¿ ALSO PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING THE RECOMMENDED INR VALUES. 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 CAUSE OF THE EPISTAXIS WAS DETERMINED TO BE DUE TO A SEPTAL DEFECT WITH SUSPECTED GRANULONASTOSIS WITH POLYANGIITIS. SERIAL COMPUTER TOMOGRAPHY (CT) SCANS WERE PERFORMED AND EAR NOSE AND THROAT (ENT) AND RHEUMATOLOGY TEAM¿S WERE INVOLVED. THE PATIENT WAS TREATED WITH NOZOIL OR FESS SALINE SPRAY TO LUBRICATE THE NOSTRIL. THE PATIENT IS STABLE AND AN OUTPATIENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED 17MAY TO 19MAY FOR EPISTAXIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293424 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524INT 7519129

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R