BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5263271 · Received December 3, 2015

    Report

    Report Number
    3007042319-2015-03338
    Event Type
    Injury
    Date Received
    December 3, 2015
    Date of Event
    November 8, 2015
    Report Date
    November 8, 2015
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. PER THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL: ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE VAD INCLUDE WARNING OF SERIOUS AND LIFE THREATENING ADVERSE EVENTS, SUCH AS NEUROLOGIC DYSFUNCTION. IFU OUTLINES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT INCLUDING MEDICAL MANAGEMENT AND THERAPEUTIC ANTICOAGULATION GUIDELINES WITH A WARNING TO MAINTAIN ANTICOAGULATION WITHIN THE RECOMMENDED INR RANGE. BASED ON THE AVAILABLE INFORMATION A DEFINITIVE CONCLUSION CANNOT BE MADE REGARDING FACTORS POTENTIALLY CONTRIBUTING TO THE REPORTED EVENT HOWEVER, IN ADDITION TO REQUIRED ADEQUATE ANTICOAGULATION, LVAD PUMP CANDIDATES OFTEN POSSESS SEVERAL RISK FACTORS FOR INTRAVASCULAR COAGULATION WHICH MAY INCLUDE ARTERIAL AND/OR VENOUS VASCULAR DISEASE, CHRONIC LOW FLOW STATE AND DECREASED MOBILITY. STROKE IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED FROM THE SITE THAT THE PATIENT HAD WIDE SWINGS OF INR AND WAS ADMITTED WITH HIGH INR AND THAT STROKE SYMPTOMS CAME AFTER PATIENT WAS ADMITTED. IT WAS SAID THAT THE PATIENT HAD A HEMORRHAGIC STROKE LIKELY EMBOLIC IN ORIGIN AND RECEIVED CONSERVATIVE TREATMENT IN THE ICU WITH NO INTERVENTION. PATIENTS INR WAS SAID TO HAVE BEEN REVERSED WITH VITAMIN K AND FFP GIVEN TO PATIENT, AND WILL BE RETURNING TO COUMADIN PLAN. IT WAS SAID THAT THERE WERE NO VAD ISSUES ASSOCIATED WITH THE EVENT. PATIENT REMAINS IN REHAB, MAKING PROGRESS AND IT IS SAID THAT THE PATIENT WILL BE DISCHARGE WITHIN A WEEK OR SO. NO ADDITIONAL INFORMATION PROVIDED. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION A DEFINITIVE CONCLUSION CANNOT BE MADE REGARDING FACTORS POTENTIALLY CONTRIBUTING TO THE REPORTED EVENT HOWEVER, IN ADDITION TO REQUIRED ADEQUATE ANTICOAGULATION, LVAD PUMP CANDIDATES OFTEN POSSESS SEVERAL RISK FACTORS FOR INTRAVASCULAR COAGULATION WHICH MAY INCLUDE ARTERIAL AND/OR VENOUS VASCULAR DISEASE, CHRONIC LOW FLOW STATE AND DECREASED MOBILITY. STROKE IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS. 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

    IT WAS REPORTED FROM THE SITE THAT THE PATIENT PRESENTED TO HOSPITAL WITH STROKE SYMPTOMS (HEADACHE AND LEFT SIDE WEAKNESS). PATIENT WAS THEN ADMITTED TO THE "NEURO ICU AFTER CODE." IT WAS STATED THAT THE PATIENT WAS FINALLY SENT TO THE FLOOR FROM THE ICU. IT WAS FURTHER STATED THAT THE PATIENT HAD LEFT SIDE HEMIPARESIS WHICH REMAINED. PATIENT HAD HIS "INR TAKEN AND ITS NOW 1.81." IT WAS ALSO STATED THAT PATIENT IS "LIKELY NOT COMPLIANT" WITH HIS ASPIRIN. NO ADDITIONAL INFORMATION PROVIDED. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793985 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization