BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5511574 · Received March 18, 2016

    Report

    Report Number
    3007042319-2016-01227
    Event Type
    Injury
    Date Received
    March 18, 2016
    Date of Event
    August 9, 2015
    Report Date
    March 1, 2016
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. THE SYSTEM IS DESIGNED TO ASSIST A WEAKENED, POORLY FUNCTIONING LEFT VENTRICLE. THE IMPLANTATION OF A VAD IS AN INVASIVE PROCEDURE REQUIRING GENERAL ANESTHESIA, MEDIAN STERNOTOMY, A VENTILATOR AND CARDIOPULMONARY BYPASS. THESE SURGICAL PROCEDURES ARE ASSOCIATED WITH NUMEROUS RISKS. SERIOUS AND LIFE THREATENING ADVERSE EVENTS HAVE BEEN ASSOCIATED WITH THE USE OF THIS DEVICE. A USER MUST FULLY CONSIDER THE RISKS OF THIS DEVICE WITH THAT OF OTHER TREATMENT MODALITIES BEFORE DECIDING TO PROCEED WITH DEVICE IMPLANTATION. GI BLEEDING/AV MALFORMATIONS, PERICARDIAL EFFUSION/TAMPONADE, PLATELET DYSFUNCTION AND SENSITIVITY TO ASPIRIN ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS. THE INSTRUCTIONS FOR USE (IFU) ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT (INCLUDING THERAPEUTIC ANTICOAGULATION GUIDELINES). THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED INCLUDE THE PATIENT'S UNIQUE ANATOMY, AND RELATED COMORBIDITIES. THERE ARE PATIENT AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) ON (B)(6) 2015 PM WITH COMPLAINTS OF WEAKNESS AND FATIGUE. IN ER HGB 5.6 G/DL (NL 13-17), HCT 18.8% (NL 39-51), PLATELETS 122 K/MCL (NL 140-450), PT/INR 23.9/2.2 SECONDS (NL 9.7-11.6). THE PATIENT RECEIVED 2 UNITS PRBC`S IN ER AND ADMITTED FOR GASTROINTESTINAL WORK UP. THE PATIENT ON NO ASA DUE TO HISTORY OF GASTROINTESTINAL BLEED. THE PATIENT WAS TAKING COUMADIN DAILY. THE PATIENT RECEIVED ANOTHER 3 UNITS OF PACKED RED BLOOD CELLS ON (B)(6) 2015. ON (B)(6) 2015 THE PATIENT HAD PUSH ENTEROSCOPY WHICH REVEALED A LARGE AMOUNT OF FRESH BLOOD IN THE DUODENUM. AN ACTIVELY BLEEDING DUODENAL ULCER WITH VISIBLE VESSEL IDENTIFIED. THIS WAS INJECTED WITH EPINEPHRINE AND TWO HEMOCLIPS WERE PLACED AND NO FURTHER BLEEDING WAS NOTED. COLONOSCOPY WAS MELENA THROUGHOUT COLON WITHOUT SOURCE. COUMADIN PLACED ON HOLD ON (B)(6) 2015 AND RESUMED 8/16/15. THE PATIENT RECEIVED TWO MORE UNITS OF PRBC`S ON (B)(6) 2015. (B)(6) 2015 HGB 8.5 G/DL, HCT 27.6. THE VITAL SIGNS ON (B)(6) 2015 BP 82/50, AND ON (B)(6) 2015 WAS 129/63. THE PATIENT WAS DISCHARGED ON (B)(6) 2015 IN A STABLE CONDITION WITH STABLE LABS. THERE WAS NO RESIDUAL SYMPTOMS FOR THE BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166897 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R