BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3910603 · Received July 2, 2014

    Report

    Report Number
    3007042319-2014-00667
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    March 9, 2014
    Report Date
    June 2, 2014
    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

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO AN OUTSIDE FACILITY WITH COMPLAINTS OF LEFT-SIDED WEAKNESS AND DISORIENTATION. UPON ADMISSION SHE WAS NOTED TO HAVE LEFT SIDED FACIAL DROOP AND WEAKNESS OF THE LEFT HAND. MULTIPLE HEAD CT SCANS WERE PERFORMED WHICH REVEALED AN ISCHEMIC STROKE. THE PATIENT BECAME COMPLETELY HEMIPLEGIC OVERNIGHT. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR THROMBECTOMY. IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TO AN INPATIENT REHABILITATION WITH REPORTS OF IMPROVEMENT IN MOBILITY. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS AS IT REMAINS IMPLANTED. STROKE IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). A USER MUST FULLY CONSIDER THE RISKS OF THIS DEVICE WITH THAT OF OTHER TREATMENT MODALITIES BEFORE DECIDING TO PROCEED WITH DEVICE IMPLANTATION. THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT INCLUDING MEDICAL MANAGEMENT AND THERAPEUTIC ANTICOAGULATION GUIDELINES TO MINIMIZE THE RISKS. WITH REVIEW OF THE AVAILABLE INFORMATION THERE IS NO INDICATION OF ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES IMPACTING THE EVENT. ALTHOUGH A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED, CLINICAL, PHARMACOLOGICAL, AND PATIENT FACTORS INCLUDING COMORBIDITIES ARE KNOWN POSSIBLE CONTRIBUTORS TO THIS TYPE OF EVENT. 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, INCLUDING TRANSPORTATION. HEARTWARE IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER FLA-14-14, DATED JUNE 2, 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803.

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED IN THE PATIENT, THEREFORE, IT WILL NOT BE RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    APPROXIMATELY TWO YEARS AND SEVEN MONTHS POST HVAD IMPLANTATION THE PATIENT WAS ADMITTED TO AN OUTSIDE FACILITY WITH COMPLAINTS OF LEFT-SIDED WEAKNESS AND DISORIENTATION FOLLOWING A FALL WHEN HER LEFT KNEE "GAVE OUT". UPON ADMISSION SHE WAS NOTED TO HAVE LEFT SIDED FACIAL DROOP AND WEAKNESS OF THE LEFT HAND. THE PATIENT WAS TAKEN FOR CT ANGIOGRAM OF THE HEAD AND NECK WHICH RESULTS WERE NEGATIVE FOR AN ACUTE PROCESS. SHE DECLINED THE FOLLOWING MORNING BECOMING COMPLETELY HEMIPLEGIC AFTER HAVING A CT OF THE HEAD. A STROKE CODE WAS CALLED AND SHE WAS SUBSEQUENTLY TAKEN FOR CT PERFUSION. RESULTS REVEALED A LARGE MISMATCH OF SALVAGEABLE TISSUE. THE PATIENT WAS NOT A CANDIDATE FOR TISSUE PLASMINOGEN ACTIVASE (TPA) BECAUSE SHE HAD FALLEN OUTSIDE OF THE RECOMMENDED WINDOW OF TREATMENT AND WAS INSTEAD TAKEN TO THE OPERATING ROOM FOR THROMBECTOMY. SHE WAS DISCHARGED FIVE DAYS LATER TO INPATIENT REHABILITATION WITH REPORTS OF IMPROVEMENT IN MOBILITY. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388492 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R BUMEX| LIPITOR| ALDACTONE| COUMADIN| ASPIRIN| KEPPRA| DIGOXIN| TOPAMAX