BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    MDR report key: 7496754 · Received May 8, 2018

    Report

    Report Number
    2916596-2018-02032
    Event Type
    Injury
    Date Received
    May 8, 2018
    Date of Event
    February 7, 2017
    Report Date
    July 13, 2018
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(4) (DOCUMENTS #151934, #152788, AND #153420) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT SHIPPED ON 19 APRIL, 2015 VIA CUSTOMER ORDER (B)(6). A DIRECT CORRELATION BETWEEN HEARTMATE II LVAS, SERIAL NUMBER (B)(4), AND THE REPORTED EVENT COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE ACCOUNT REPORTED THAT THE PATIENT SUFFERED FROM A SECOND CEREBROVASCULAR ACCIDENT (CVA) AND WAS ADMITTED TO THE HOSPITAL. A CT SCAN CONFIRMED EVIDENCE OF A STROKE. THE PATIENT DID NOT ENCOUNTER ANY LASTING EFFECTS FOLLOWING THE EVENT. PLAVIX WAS ADDED TO THE PATIENT¿S MEDICATION REGIMEN. HEARTMATE II LVAS IFU LISTS STROKE AND BLEEDING AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. THE PATIENT REMAINS ON VAD SUPPORT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). AGE OF DEVICE: 1 YEAR, 9 MONTHS AND 2 DAYS. THE PATIENT REMAINS ONGOING WITH THE DEVICE. 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 A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2015. IT WAS REPORTED THAT PATIENT HAD A SECOND STROKE ON (B)(6) 2017 AND SHOWED OCULAR SYMPTOMS. THE PATIENT WAS SYMPTOMATIC. A CT SCAN WAS DONE SUBSEQUENT TO THE EVENT ON (B)(6) 2017 AND PATIENT WAS DIAGNOSED WITH ACUTE/EARLY SUBACUTE LEFT POSTERIOR CEREBRAL ARTERY (PCA) ISCHEMIC INFARCT WITH CENTRAL HEMORRHAGIC TRANSFORMATION. OTHER POSSIBLE ETIOLOGIES INCLUDED INTRAPARENCHYMAL HEMORRHAGE OR HEMORRHAGIC TUMOR WITH SURROUNDING EDEMA. A SMALL RIGHT POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) ISCHEMIC INFARCT (SUBACUTE) AND LEFT MIDDLE CEREBRAL ARTERY (MCA) ISCHEMIC INFARCT (SUBACUTE) IN THE LEFT POSTERIOR FRONTAL LOBE WERE ALSO OBSERVED. PATIENT DID NOT ENCOUNTER ANY LASTING EFFECT AFTER THE STROKE. PLAVIX WAS ADDED TO PATIENT'S MEDICATION REGIMEN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338193 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R