BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM-PUMP

    MDR report key: 6893245 · Received September 26, 2017

    Report

    Report Number
    3007042319-2017-03271
    Event Type
    Injury
    Date Received
    September 26, 2017
    Date of Event
    April 1, 2014
    Report Date
    February 22, 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
    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. WITH A REVIEW OF THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO INDICATE ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES THAT WOULD IMPACT THE REPORTED EVENTS. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT¿S PRE-EXISTING 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. 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

    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. JACC: HEART FAILURE: 2014 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION ISSN 2213-1779/$36.00 PUBLISHED BY ELSEVIER INC. PUBLISHED BY ELSEVIER INC. HTTP://DX.DOI.ORG/10.1016/J.JCHF.2013.10.008 ACQUIRED VON WILLEBRAND SYNDROME IN PATIENTS WITH A CENTRIFUGAL OR AXIAL CONTINUOUS FLOW LEFT VENTRICULAR ASSIST DEVICE ANNA L. MEYER, MD,* DORIS MALEHSA, MD,Y ULRICH BUDDE, MD,Z CHRISTOPH BARA, MD,Y AXEL HAVERICH, MD,Y MARTIN STRUEBER, MD* LEIPZIG, HANNOVER, AND HAMBURG, GERMANY. (B)(4). 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 JOURNAL ARTICLE WAS RECEIVED THAT INCLUDED A REPORT OF 14 CASES OF THROMBUS FORMATION IN LEFT VENTRICULAR ASSIST DEVICE (LVAD), FOUR TRANSIENT ISCHEMIC ATTACK (TIAS), SIX EVENTS OF CEREBRAL ISCHEMIA, 22 CASES OF POSTOPERATIVE BLEEDING EVENTS REQUIRING RE-EXPLORATION, SIX EVENTS OF GASTROINTESTINAL (GI) BLEEDING, FOUR EVENTS OF EPISTAXIS, FOUR EVENTS OF CEREBRAL BLEEDING, AND SIX EVENTS OF OTHER BLEEDING (SUCH AS HEMATURIA). DURING THE FOLLOW-UP PERIOD, PUMP THROMBOSES WERE FOUND IN SEVEN PATIENTS. IN ALL PATIENTS, THE PUMP HAD TO BE EXCHANGED. POSTOPERATIVE BLEEDING WAS DEFINED AS ANY BLEEDING DURING HOSPITAL STAY AFTER IMPLANTATION REQUIRING REOPERATION. GASTROINTESTINAL BLEEDING WAS DEFINED AS CONFIRMED BY ENDOSCOPY OR REQUIRING TREATMENT WITH A TRANSFUSION OF PACKED RED BLOOD CELLS. EPISTAXIS WAS INCLUDED IF IT REQUIRED HOSPITAL STAY AND A TRANSFUSION OF PACKED RED BLOOD CELLS, , PACKING, OR CAUTERIZATION. OTHER BLEEDING, SUCH AS HEMATURIA, WAS DOCUMENTED IF A PACKED RED BLOOD CELL TRANSFUSION OR AN INTERVENTION WAS NECESSARY. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO DETERMINE WHETHER DIFFERENCES IN CONTINUOUS FLOW LEFT VENTRICULAR ASSIST DEVICES (LVADS) MAY LEAD TO DIFFERENCES IN THE VON WILLEBRAND PROFILE AND THE OCCURRENCE OF BLEEDING AND THROMBOEMBOLIC EVENTS. DEMOGRAPHIC DATA WERE COLLECTED, AND BLEEDING AND THROMBOEMBOLIC EVENTS WERE FOLLOWED FROM THE DAY OF IMPLANTATION FOR A MINIMAL OF 180 DAYS POST-IMPLANTATION. THE RESULTS WERE AVAILABLE FOR 51 PATIENTS AND SIXTEEN WERE REPORTED TO HAVE BEEN FEMALE. THE MEAN AGE WAS 49.6 YEARS. THE MEDIAN DAYS OF SUPPORT WAS 664 DAYS. THE TOTAL FOLLOW-UP PERIOD WAS 92.7 PATIENT-YEARS. ACQUIRED VON WILLEBRAND SYNDROME (AVWS) DEVELOPED IN ALL PATIENTS AFTER CENTRIFUGAL OR AXIAL FLOW PUMP IMPLANTATION. DIFFERENCE PATTERNS OF AVWS WERE SEEN BETWEEN THE DEVICES AS WELL AS INDIVIDUALLY. HOWEVER, THE COMPLICATION RATES AFTER IMPLANTATION WERE SIMILAR. FURTHER FOLLOW UP REVEALED THAT THE SITE WOULD NOT PROVIDE PATIENT DATA DUE TO PRIVACY LAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675534 HEARTWARE® VENTRICULAR ASSIST SYSTEM-PUMP CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R