BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 12004864 · Received June 15, 2021

    Report

    Report Number
    2916596-2021-03018
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    August 18, 2017
    Report Date
    August 23, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED EVENTS, AS WELL AS A DIRECT CORRELATION TO HEARTMATE II LVAS, SERIAL NUMBER (B)(6), COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. THE PATIENT REMAINED ONGOING ON HEARTMATE II LVAS, SERIAL NUMBER (B)(6) UNTIL THEY UNDERWENT PUMP EXCHANGE ON (B)(6) 2021 (REFER TO MFR# 2916596-2021-02768). 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 20SEP2016. THE HEARTMATE II LVAS IFU IS CURRENTLY AVAILABLE. SECTION 1 ENTITLED ¿INTRODUCTION¿ LISTS PERIPHERAL THROMBOEMBOLIC EVENTS, BLEEDING AND HEMOLYSIS AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. THE SECTION OF THIS DOCUMENT ENTITLED ¿ANTICOAGULATION THERAPY¿ PROVIDES DETAILS REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S ADMISSIONS FOR ANEMIA/BLEEDING ARE REFERENCED IN MFR NUMBERS 2916596-2021-03013, 2916596-2021-03023, 2916596-2021-03025, 2916596-2021-03026, 2916596-2021-03027, 2916596-2021-03032, 2916596-2021-03034, 2916596-2021-03035, 2916596-2021-03036. THE PATIENT'S PRIOR ADMISSIONS FOR THROMBUS/ISCHEMIA ARE REFERENCED IN MFR NUMBERS : 2916596-2021-03016, 2916596-2021-030, 2916596-2021-02768.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED (B)(6) 2017 FOR ELEVATED LACTATE DEHYDROGENASE (LDH), PUMP THROMBOSIS, AND LEFT GROIN HEMATOMA. TISSUE PLASMINOGEN ACTIVATOR (TPA) TREATMENT WAS ADMINISTERED. THE ELEVATED LDH WAS DETERMINED TO BE RELATED TO LEFT LOWER EXTREMITY (LLE) THROMBOSIS CONSISTENT WITH ACUTE LIMB ISCHEMIA. VASCULAR SURGERY WAS PERFORMED ANGIO AND STENT OF LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH RESULTING DOWNWARD TREND IN LDH. THE ANTICOAGULATION THERAPY FOR THROMBUS LED TO GASTROINTESTINAL BLEEDING/ANEMIA ON (B)(6) 2017. ESOPHAGOGASTRODUODENOSCOPY (EGD) SHOWED ESOPHAGITIS AND GASTROPATHY. HEMOGLOBIN COUNT WAS 5 ON ADMISSION. NUCLEAR MEDICAL SCAN ON (B)(6) 2017 SHOWED LOW GRADE BLEEDING IN SMALL BOWEL AND ON (B)(6) EX LAP SMALL BOWEL RESECTION WAS DONE. SMALL BOWEL ENTEROSCOPY SHOWED A SINGLE ANGIODYSPLASTIC LESION IN THE ILEUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896841 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R