BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    MDR report key: 7737931 · Received July 31, 2018

    Report

    Report Number
    2916596-2018-03156
    Event Type
    Injury
    Date Received
    July 31, 2018
    Date of Event
    July 2, 2017
    Report Date
    October 18, 2018
    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

    DEVICE EVALUATION: A DIRECT RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED GI BLEEDING COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE EVALUATION OF HEARTMATE II LVAS, SERIAL NUMBER (B)(4) DID NOT REVEAL ANY FUNCTIONAL ISSUES. (B)(4) WAS RETURNED ASSEMBLED WITH THE PERCUTANEOUS LEAD CUT APPROXIMATELY 9 INCHES FROM THE PUMP HOUSING AND THE SEVERED PORTION OF THE DRIVELINE WAS NOT RETURNED. ALL PARTS OF THE SEALED INFLOW CONDUIT (THE INLET TUBE, INFLOW CONDUIT FLEX SECTION, AND INLET ELBOW) WERE RETURNED. THE SEALED OUTFLOW GRAFT AND OUTFLOW GRAFT BEND RELIEF WERE RETURNED. THE PUMP APPEARED TO BE EXPOSED TO A FIXATIVE. EVALUATION OF THE SEALED INFLOW AND OUTFLOW CONDUITS REVEALED NO EVIDENCE OF DEVELOPED DEPOSITIONS OR THROMBUS FORMATIONS. VISUAL EXAMINATION OF THE PUMP¿S BLOOD-CONTACTING SURFACES UPON DISASSEMBLY OF (B)(4) SHOWED FIXED, POST-EXPLANT BLOOD THROUGHOUT THE INSIDE OF THE PUMP, HOWEVER, THERE WAS NO EVIDENCE OF DEVELOPED DEPOSITIONS OR THROMBUS FORMATIONS. THE DISASSEMBLED PUMP¿S BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES WERE EXAMINED UNDER A MICROSCOPE AND NO ANOMALIES WERE OBSERVED. ELECTRICAL CONTINUITY TESTING OF THE DRIVELINE DID NOT REVEAL ANY DISCONTINUITIES OR SHORTS. THE PUMP WAS CLEANED, REASSEMBLED AND FUNCTIONALLY TESTED UNDER NORMAL OPERATING CONDITIONS USING A MOCK CIRCULATORY LOOP. THE DATA RETRIEVED FROM THAT TESTING REVEALED NORMAL PUMP POWER CONSUMPTION AND PRESSURE VALUES, COMPARABLE TO WHAT WAS RECORDED DURING THE MANUFACTURING PROCESS AND THE DEVICE FUNCTIONED AS INTENDED. REVIEW OF THE DEVICE HISTORY RECORDS (DOCUMENTS 179924, 178856, 183239) SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE FOR THIS EVENT.

    Description of Event or Problem · 0

    CORRECTED INFORMATION: ASPIRIN WAS HELD ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT UNDERWENT A HEART TRANSPLANT.

    Additional Manufacturer Narrative · 1

    AGE OF DEVICE: 1 YEAR, 4 MONTHS, 19 DAYS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2017. IT WAS REPORTED THAT PATIENT WAS PLACED ON THE TRANSPLANT LIST DUE TO RECURRENT GASTROINTESTINAL BLEED (GIB). THE PATIENT'S GIB STARTED SHORTLY AFTER LVAD IMPLANT. SYMPTOMS INCLUDED DARK STOOLS AND LOW HEMOGLOBIN. THE PATIENT UNDERWENT BLOOD TRANSFUSION. ESOPHAGOGASTRODUODENOSCOPY (EGD) AND COLONOSCOPY WERE PERFORMED ON (B)(6) 2017 AND (B)(6) 2017 RESPECTIVELY, BUT NOTHING REMARKABLE WAS FOUND. ON (B)(6) 2017, AN EGD WITH PILL CAMERA WAS PERFORMED AND ARTERIOVENOUS MALFORMATIONS (AVM) WERE DETECTED PROXIMAL TO JEJUNUM. ON (B)(6) 2017, THESE WERE INJECTED WITH EPINEPHRINE AND CAUTERIZED. ANTICOAGULATION WAS HELD PRIOR TO ALL GIB PROCEDURES TO ALLOW INR LESS THAN 2. ON (B)(6) 2017, INR GOAL ADJUSTED DOWN TO 2-2.5 . ASPIRIN WAS HELD ON (B)(6) 2018. ON (B)(6) 2018 THE PATIENT UNDERWENT A HEART TRANSPLANT. THE PATIENT'S GIB RESOLVED AFTER THE TRANSPLANT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576153 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 5726609 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R