BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP(S)

    MDR report key: 6677020 · Received June 29, 2017

    Report

    Report Number
    3007042319-2017-02049
    Event Type
    Injury
    Date Received
    June 29, 2017
    Report Date
    February 13, 2018
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PUMPS WITH UNKNOWN SERIAL NUMBERS WERE NOT RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE PUMPS COULD NOT BE PERFORMED DUE TO SERIAL NUMBER BEING UNKNOWN. LOG FILE ANALYSIS BASED ON A SCREEN SHOT (FIGURE 2) PROVIDED IN THE JOURNAL ARTICLE SHOWED A SUSTAINED DECREASE IN ESTIMATED FLOW STARTING (B)(6) 2015. A SECOND SCREEN SHOT (FIGURE 3) IN THE JOURNAL ARTICLE SHOWED A DECREASE IN ESTIMATED FLOW STARTING (B)(6) 2013. NO INFORMATION ON ALARMS FOR BOTH EVENTS WAS PROVIDED. BASED ON RISK DOCUMENTATION, THE POSSIBLE ROOT CAUSES OF THE REPORTED EVENT OF LOW FLOWS MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING BUT NOT LIMITED TO INCORRECT PLACEMENT OF THE PUMP DURING IMPLANT, OBSTRUCTION OF THE INFLOW CANNULA, INAPPROPRIATE SETTING OF THE PUMP ROTATIONAL SPEED, AND A KINK IN THE OUTFLOW GRAFT. BASED ON RISK DOCUMENTATION, THE MOST LIKELY ROOT CAUSE OF HIGH POWER CAN BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING BUT NOT LIMITED TO THROMBUS FORMATION/INGESTION, HIGH FLOWS, HIGH SPEED. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS INCLUDE THE PATIENTS' PAST MEDICAL HISTORY AND RELATED COMORBIDITIES AND POSSIBLE ISSUES WITH THERAPEUTIC ANTICOAGULATION AND ANTIPLATELET MEDICATIONS. THERE ARE POSSIBLE PATIENT AND PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THESE EVENTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    DIAGNOSIS AND TREATMENT ALGORITHM FOR BLOOD FLOW OBSTRUCTIONS IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICE. ANNA MARA SCANDROGLIO, MD,A FRIEDRICH KAUFMANN, DIPL ING,B MARINA PIERI, MD,A ALEXANDRA KRETZSCHMAR, MD,B MARCUS MÜLLER, MD,B PANAGIOTIS PERGANTIS, MD,C STEPHAN DREYSSE, MD,C VOLKMAR FALK, MD, PHD,B,D,E THOMAS KRABATSCH, MD, PHD,B,D EVGENIJ V. POTAPOV, MD, PHDB,D. REPORT SOURCE: UNCHECKED "HEALTH PROFESSIONAL". 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 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. REASON FOR NO RETURN CHANGED TO UNKNOWN SINCE A NUMBER OF PUMPS WERE EXCHANGED. THE SYSTEM IS DESIGNED TO ASSIST A WEAKENED, POORLY FUNCTIONING LEFT VENTRICLE. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), HIGH WATT AND LOW FLOW MAY BE INDICATIVE OF THROMBUS OR OTHER TISSUE FRAGMENTS IN THE PUMP, WHICH ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS AS OUTLINED IN THE LABELING. THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT (INCLUDING THERAPEUTIC ANTICOAGULATION GUIDELINES). DEATH AND DEVICE THROMBOSIS ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF THESE DEVICES. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. UNKNOWN (LITERATURE ARTICLE).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED VIA A LITERATURE ARTICLE ENTITLED "DIAGNOSIS AND TREATMENT ALGORITHM FOR BLOOD FLOW OBSTRUCTIONS IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICE".THIS ARTICLE PRESENTED A RETROSPECTIVE STUDY THAT ANALYZED THE SITE'S EXPERIENCE WITH OBSTRUCTIONS OF BLOOD FLOW THROUGH LVADS TO DEVELOP OPTIMAL DIAGNOSIS AND TREATMENT OF LVAD-RELATED THROMBOSIS. THE AUTHORS REPORTED THAT BETWEEN OCT-2009 AND JUL-2015, A TOTAL OF 652 LVADS WERE IMPLANTED IN 557 PATIENTS AND THAT 524 OF THESE LVADS REVEALED BLOOD FLOW ABNORMALITIES THAT WERE CLASSIFIED AS HIGH POWER OR LOW FLOW EVENTS. THE RESULTS OF THE STUDY REVEALED THAT THERE WERE THREE TYPES OF LATE BLOOD FLOW OBSTRUCTIONS: PRE-PUMP VIA THROMBUS OBSTRUCTING THE INFLOW CANNULA (26 EVENTS); INTRA-PUMP (70 EVENTS); AND POST-PUMP VIA THROMBOSIS OF THE OUTFLOW GRAFT OR STENOSIS OF THE AORTIC ANASTOMOSIS (4 EVENTS). PRE-PUMP OBSTRUCTION WAS TREATED BY WASHOUT MANEUVER IN 9 CASES (SUCCESS RATE OF 100%), THROMBOLYSIS IN 9 PATIENTS (SUCCESS RATE OF 56%) AND PUMP EXCHANGE IN 9 CASES (SUCCESS RATE OF 100%). ONE PATIENT DIED WITHOUT TREATMENT (REPORTED SEPARATELY) AND TWO PATIENTS THAT WERE WEANED FROM LVAD. INTRA-PUMP OBSTRUCTION WAS TREATED BY THROMBOLYSIS IN 9 CASES (SUCCESS RATE OF 33%), PUMP EXCHANGE IN 53 CASES (SUCCESS RATE OF 94%) AND REMOVAL DUE TO MYOCARDIAL RECOVERY IN 3 CASES (SUCCESS RATE OF 100%). SEVEN PATIENTS DIED WITHOUT TREATMENT (REPORTED SEPARATELY) AND PARAMETERS SPONTANEOUSLY NORMALIZED IN TWO CASES. POST-PUMP OBSTRUCTION WAS TREATED IN TWO PATIENTS WITH STENTING (SUCCESS RATE OF 100%) AND WAS LEFT UNTREATED IN TWO CASES. THE AUTHORS CONCLUDED THAT THEY WERE ABLE TO IDENTIFY THREE TYPES OF LVAD-RELATED BLOOD FLOW OBSTRUCTION AND DEVELOPED AN ALGORITHM FOR OPTIMAL DIAGNOSIS AND TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457637 HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP(S) CIRCULATORY ASSIST SYSTEM, DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R