BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4975811 · Received August 5, 2015

    Report

    Report Number
    2916596-2015-01459
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    March 6, 2015
    Report Date
    July 13, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE ¿ 10 MONTHS. (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. (B)(4). THE USER FACILITY NUMBER WAS NOT PROVIDED. THE (B)(4) IDENTIFIER IS (B)(4). NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    A FULL EVALUATION OF THE DEVICE COULD NOT BE CONDUCTED AS THE DEVICE WAS NOT RETURNED BY THE HOSPITAL. A CORRELATION BETWEEN THE DEVICE AND THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE LISTS DEVICE THROMBOSIS, HEMOLYSIS AND BLEEDING AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. INFORMATION WAS RECEIVED FROM THE (B)(4) ON (B)(6) 2015 STATING: ELEVATED LDH, SOB, +JVD. POWER SPIKES. NO COUMADIN D/T GI BLEED. PUMP THROMBUS SUSPECTED. ON (B)(6) TPA INFUSION PROTOCOL STARTED. VAD FUNCTION STABLE. IV HEPARIN STARTED AND STOPPED D/T LOWER GI BLEED. PLATELET INHIBITION ONLY. LISTED FOR OHT 1A. REPEAT TPA DOSING (B)(6) D/T ELEVATED LDH. MILRINONE STARTED (B)(6). OHT (B)(6). ADDITIONAL INFORMATION ALSO INCLUDED THAT THE PATIENT UNDERWENT AN URGENT TRANSPLANTATION. PATIENT OUTCOME: URGENT TRANSPLANTATION. THROMBUS EVENT SIGNS OR SYMPTOMS: HEMOLYSIS, ABNORMAL PUMP PARAMETERS. THROMBUS EVENT: INTRAVENOUS ANTICOAGULATION. THROMBUS EVENT CONFIRMED: NO. DEVICE MALFUNCTION CAUSATIVE FACTOR: SUB THERAPEUTIC ANTICOAGULATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: INFORMATION PROVIDED BY THE VAD COORDINATOR ON 12/21/2015 INDICATED THAT THE LVAD PUMP WILL NOT BE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515258 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R