BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3601517 · Received January 31, 2014

    Report

    Report Number
    3007042319-2014-00056
    Event Type
    Injury
    Date Received
    January 31, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 2, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE PUMP WAS EXPLANTED, AN ANALYSIS OF THE RETURNED DEVICE IS NOT REQUIRED FOR THIS INVESTIGATION. BASED ON THE CONCLUSIONS OF THE (B)(4) AUTHORS, THIS EVENT WAS MOST LIKELY RELATED TO MECHANICAL IRRITATION BY THE VAD OF THE PATIENT'S NEWLY RE-MODELED VENTRICLE. NO ADDITIONAL INFORMATION WILL BE FORTHCOMING.

    Additional Manufacturer Narrative · 1

    BIBLIOGRAPHY- YALIN YILDIRIM, SIMON PECHA, HERMANN REICHENSPURNER, AND TOBIAS DEUSE : MECHANICALLY INDUCED VENTRICULAR TACHYCARDIA BY THE HEARTWARE VENTRICULAR ASSIST DEVICE ASAIO JOURNAL 2014; 60:124-126. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    HEARTWARE IS SUBMITTING THIS CORRECTION TO A PREVIOUSLY SUBMITTED MDR 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.

    Description of Event or Problem · 1

    COMPLAINT FROM LITERATURE ARTICLE: ASAIO JOURNAL 2014; 60:124-126. APPROXIMATELY SIX MONTHS AFTER THE IMPLANTATION, THE PATIENT REPORTED PALPITATIONS WITH RECURRENT EPISODES OF DIZZINESS, ESPECIALLY WHEN BENDING FORWARD. THE PATIENT'S ICD WAS INTERROGATED AND THIS REVEALED THAT THE PATIENT HAD HAD FREQUENT OCCURRENCES OF SELF-TERMINATING VENTRICULAR TACHYCARDIA. THE PATIENT'S PREVIOUS ECHOCARDIOGRAMS WERE REVIEWED AND DEMONSTRATED THAT THE INFLOW CANNULA WAS COMING IN CONTACT WITH THE INFERIOR-POSTERIOR WALL OF THE NOW REMODELED HEART. THE PATIENT WAS EVALUATED FOR POTENTIAL VAD EXPLANTATION THROUGH PUMP STOP TRIALS AND THE HEARTWARE VAD EXPLANTED NINE MONTHS AFTER THE IMPLANTATION WITH NO FURTHER ARRHYTHMIAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67212 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization ICD| COUMADIN| ASPIRIN (100 MG)