BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5258728 · Received December 1, 2015

    Report

    Report Number
    3007042319-2015-03297
    Event Type
    Injury
    Date Received
    December 1, 2015
    Date of Event
    May 14, 2014
    Report Date
    May 21, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO THE PROCEDURE, THERAPY OR USE OF THE DEVICE. IT IS MOST LIKELY RELATED TO THE PROGRESSION OF THE PATIENT'S UNDERLYING CONDITION. THE SITE REPORTED THAT THE PATIENT HAD BEEN NONCOMPLIANT WITH MEDICAL THERAPY AND HAD A CRTD DEVICE WITH A ERI INDICATOR REQUIRING ELECTIVE REPLACEMENT. IN ADDITION, THE PI REPORTED THAT THE EVENTS WERE RELATED TO THE PATIENT'S CONDITION AND UNRELATED TO THE STUDY DEVICE OR IMPLANT PROCEDURE. A REASSESSMENT OF THESE EVENTS DETERMINED THAT THE FILE IS NO LONGER REPORTABLE TO ANY COMPETENT AUTHORITY. 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. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THIS PATIENT EXPERIENCED AN INTERNAL CARDIOVERTER DEFIBRILLATOR (ICD) SHOCK DUE TO VENTRICULAR TACHYCARDIA. THE PATIENT WAS SEEN BY ELECTROPHYSIOLOGY (EP). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS AS IT REMAINS IMPLANTED. THE IMPLANTATION OF A VAD IS AN INVASIVE PROCEDURE REQUIRING GENERAL ANESTHESIA, MEDIAN STERNOTOMY, A VENTILATOR AND CARDIOPULMONARY BYPASS. A USER MUST FULLY CONSIDER THE RISKS OF THIS DEVICE WITH THAT OF OTHER TREATMENT MODALITIES BEFORE DECIDING TO PROCEED WITH DEVICE IMPLANTATION. THESE SURGICAL PROCEDURES ARE ASSOCIATED WITH NUMEROUS RISKS. CARDIAC ARRHYTHMIAS ARE A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE IMPLANTATION OF ALL VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE. WITH REVIEW OF THE AVAILABLE INFORMATION THERE IS NO INDICATION OF ANY DEVICE MALFUNCTION OR PERFORMANCE ISSUES IMPACTING THE EVENT. ALTHOUGH A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED, CLINICAL, PHARMACOLOGICAL, AND PATIENT FACTORS INCLUDING COMORBIDIES 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. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. HEARTWARE IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER (B)(4), DATED JUNE 2, 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803. THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE UNITES STATES ON 14 MAY 2014 THAT THIS PATIENT WAS ADMITTED TO THE HOSPITAL BECAUSE OF AN INTERNAL CARDIOVERTER DEFIBRILLATOR (ICD) SHOCK FOR VENTRICULAR TACHYCARDIA (VT) IN THE SETTING OF AN EXTRA DIURETIC DOSE. IT WAS PRESUMED THAT THE VT WAS DUE TO LOW POTASSIUM FROM THE EXTRA DIURESIS. THE PATIENT WAS SEEN BY ELECTROPHYSIOLOGY (EP) PRIOR TO DISCHARGE. THE PUMP REMAINS IMPLANTED AND WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788962 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L