BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM-PUMP

    MDR report key: 6814471 · Received August 23, 2017

    Report

    Report Number
    3007042319-2017-02795
    Event Type
    Injury
    Date Received
    August 23, 2017
    Date of Event
    January 1, 2013
    Report Date
    November 21, 2017
    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

    HVAD PUMP WITH UNKNOWN SERIAL NUMBER WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED SINCE THE PUMP SERIAL NUMBER IS UNKNOWN. REVIEW OF LOG FILES COULD NOT BE PERFORMED SINCE LOG FILES WERE NOT PROVIDED FOR ANALYSIS. BASED ON THE INVESTIGATION CONDUCTED, THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT¿S PREEXISTING HISTORY AND RELATED COMORBIDITIES, THE PROGRESSION OF THEIR UNDERLYING DISEASE, ISSUES RELATED TO THE THERAPEUTIC USE OF ANTICOAGULANT AND ANTIPLATELET MEDICATIONS AND THE PATIENT'S COMPLEX POST-OPERATIVE COURSE. THE AUTHORS REPORTED THAT THE ASSUMED CAUSE OF THE EVENT WAS PLAQUE EMBOLIZATION FROM A LV THROMBUS. THERE ARE POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT FURTHER DETAILS WILL NOT BE FORTHCOMING IN THE NEXT FEW WEEKS SINCE THESE EVENTS WERE NOT RECORDED ON DIGITAL FILES AND WOULD NEED TO BE REVIEWED MANUALLY. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    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. ASAIO JOURNAL 2012. FROM THE DEPARTMENT OF CARDIOTHORACIC AND VASCULAR SURGERY, DEUTSCHES HERZZENTRUM BERLIN, BERLIN, GERMANY. EVGENIJ V. POTAPOV, ALEXANDER STEPANENKO, FRIEDRICH KAUFMANN, EWALD HENNING, JULIANA VIERECKE, ELKE LEHMKUHL, ROLAND HETZER, AND THOMAS KRABATSCH 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

    A REPORT WAS RECEIVED VIA A LITERATURE ARTICLE ENTITLED "THROMBOSIS AND CABLE DAMAGE IN THE HEARTWARE PUMP: CLINICAL DECISIONS AND SURGICAL TECHNIQUE".  THIS ARTICLE DISCUSSED THE AUTHORS' EXPERIENCE WITH LVAD EXCHANGE IN PATIENTS WHO HAD DEVELOPED PUMP THROMBOSIS, INFECTION OR DRIVELINE CABLE DAMAGE. THEY REPORTED THAT THEY HAD A TOTAL OF 225 PATIENTS WITH LVAD SUPPORT BETWEEN SEP-2009 AND APR-2012 AT THEIR INSTITUTION. THE MEAN AGE OF THESE PATIENTS WAS 55.4 YEARS OF AGE; WITH 40 OF THESE PATIENTS BEING FEMALE. SIX OF THESE PATIENTS HAD DEVELOPED EARLY PUMP THROMBOSIS (<30 DAYS), SIX HAD DEVELOPED LATE THROMBOSIS REQUIRING PUMP EXCHANGE THAT HAD OCCURRED BETWEEN TWO TO NINE DAYS AFTER IMPLANT. SIX PATIENTS DEVELOPED LATE PUMP THROMBOSIS REQUIRING PUMP EXCHANGE THAT HAD OCCURRED BETWEEN 84 TO 705 DAYS AFTER IMPLANT. TWO PATIENTS HAD REQUIRED PUMP EXCHANGE AS A RESULT OF ACCIDENTAL CABLE DAMAGE AS A RESULT OF MASSIVE EXTERNAL MECHANICAL IMPACT. IN THIS ARTICLE, THE AUTHORS DESCRIBE THE USE OF A LEFT THORACOTOMY APPROACH FOR THE EXPLANT AND EXCHANGE OF THESE PUMPS. THE ARTICLE INCLUDES A REPORT THROMBUS PATIENT 11 WHO WAS INITIALLY IMPLANTED WITH AN LVAD WITH A NON-SINTERED INFLOW CANNULA WHO DEVELOPED PUMP THROMBOSIS 84 DAYS POST-IMPLANT. THE ASSUMED CAUSE OF THIS EVENT WAS REPORTED TO BE PLAQUE EMBOLIZATION FROM A LEFT VENTRICULAR (LV) THROMBUS. THE PATIENT'S PUMP WAS EXCHANGED AND THE PATIENT DISCHARGED HOME AT A LATER DATE. THE AUTHORS CONCLUDED THAT PUMP THROMBOSIS IS A VERY RARE CONDITION CAUSED MOSTLY BY NEW ONSET HEPARIN-INDUCED THROMBOCYTOPENIA (HIT), MISMANAGEMENT OF ANTICOAGULATION OR HYPERCOAGULABILITY IN THE SETTING OF SEPSIS. PUMP EXCHANGE IN THE CASE OF HEMOLYSIS SHOULD NOT BE DELAYED. THEY FURTHER REPORTED THAT THE DEVICE CABLE IS VERY RELIABLE AND BREAKS ONLY AFTER EXCESSIVE EXTERNAL IMPACT. THEY RECOMMEND A MINIMALLY INVASIVE APPROACH FOR PUMP EXCHANGE ON CARDIOPULMONARY BYPASS AND OFF-PUMP FOR CABLE DAMAGE OR PUMP EXPLANTATION. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595889 HEARTWARE® VENTRICULAR ASSIST SYSTEM-PUMP CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| L| R