BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4926304 · Received July 20, 2015

    Report

    Report Number
    3007042319-2015-01521
    Event Type
    Injury
    Date Received
    July 20, 2015
    Date of Event
    June 19, 2015
    Report Date
    June 20, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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): SERIOUS AND LIFE THREATENING ADVERSE EVENTS, INCLUDING DEATH, NEUROLOGICAL DYSFUNCTION, AND THROMBUS HAVE BEEN ASSOCIATED WITH USE OF THIS DEVICE AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). THE IFU INDICATES THAT ANTICOAGULATION SHOULD BE INDIVIDUALIZED FOR EACH PATIENT. WHILE THERE IS NO EVIDENCE BASED ON THE AVAILABLE INFORMATION, IT MAY BE POSSIBLE THAT THERE WERE SOME UNDERLYING HEALTH CONDITIONS THAT COULD HAVE PREDISPOSED THE PATIENT TO THIS EVENT. THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT INCLUDING PRE AND POST-OPERATIVE INCLUDE ARTERIAL AND/OR VENOUS VASCULAR DISEASE, CHRONIC LOW FLOW STATE AND DECREASED MOBILITY. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT HAS NO NEUROLOGICAL DEFECTS LEFT. THE PATIENT IS STILL IN THE HOSPITAL AND IS LISTED AS "HIGH URGENT" FOR TRANSPLANT DUE TO THE CHRONIC DRIVELINE INFECTION WITH SERRATIA MARCESCENS. THE HEARTWARE VAD 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, INCLUDING TRANSPORTATION. PER THE INSTRUCTIONS FOR USE (IFU): SERIOUS AND LIFE THREATENING ADVERSE EVENTS, INCLUDING DEATH AND INFECTION HAVE BEEN ASSOCIATED WITH USE OF THIS DEVICE AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). THE IFU INDICATES THAT ANTICOAGULATION SHOULD BE INDIVIDUALIZED FOR EACH PATIENT. WHILE THERE IS NO EVIDENCE BASED ON THE AVAILABLE INFORMATION, IT MAY BE POSSIBLE THAT THERE WERE SOME UNDERLYING HEALTH CONDITIONS THAT COULD HAVE PREDISPOSED THE PATIENT TO THIS EVENT. THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT INCLUDING PRE AND POST-OPERATIVE INFECTION CONTROL MEASURES.

    Additional Manufacturer Narrative · 1

    DRIVELINE SITE INFECTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF ALL VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). THE IFU AND PATIENT MANUAL ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT INCLUDING PRE AND POST-OPERATIVE INFECTION CONTROL MEASURES AND DRIVELINE CARE. ALTHOUGH A DEFINITIVE CONCLUSION CANNOT BE MADE REGARDING THE ROOT CAUSE OF THE REPORTED INFECTION, PATIENT FACTORS INCLUDING DRIVELINE EXIT SITE MANAGEMENT AND PATIENT COMORBIDITIES MAY INCREASE THE RISK OF INFECTION; WITH NO INDICATION OF ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES. NEUROLOGICAL DYSFUNCTION 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 STATUS, COMORBIDITIES, AND PHARMACOLOGICAL FACTORS ARE POSSIBLE CONTRIBUTING FACTORS. 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 (B)(6) BY THE PERFUSIONIST THAT THE PATIENT WAS HOSPITALIZED DUE TO DRIVELINE INFECTION (UNKNOWN WHEN BEGAN) AND REPORTED DIZZINESS AND VISUAL PROBLEMS SINCE YESTERDAY. YESTERDAY PATIENT INR WAS >4, TODAY 3. HE REPORTED FLUTTERING BEHAVIOR OF THE PUMP WHEN HIS DIZZINESS AND VISUAL PROBLEMS STARTED. NEUROLOGICAL CONSULT ORDERED AND ALSO ECHO TO INVESTIGATE INTO VOLUME STATUS AND RIGHT HEART FUNCTION, INCE FLOWS SEEM TO BE LOW. NO FURTHER INFORMATION AT THIS TIME. INVESTIGATION IS IN PROGRESS. NOTE: THIS REPORT IS FOR THE NEUROLOGICAL DYSFUNCTION ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468275 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R