BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM - UNK-PUMP

    MDR report key: 6864987 · Received September 14, 2017

    Report

    Report Number
    3007042319-2017-03134
    Event Type
    Injury
    Date Received
    September 14, 2017
    Date of Event
    September 1, 2016
    Report Date
    August 16, 2017
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY: MEDICAL DEVICE: HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP. SERIAL NUMBER: (B)(4) / CATALOG NUMBER 1103 / EXPIRATION DATE: 31-MAY-2016. DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE EVALUATED BY MFR?: NO, PRODUCT NOT RETURNED - NOT RETURNED TO MANUFACTURER. LABELED FOR SINGLE USE?: YES. (B)(4). THE DEVICES REMAIN IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER. 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. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. REFERENCED ARTICLE: ASAIO JOURNAL 2016. DOI: 10.1097/MAT.0000000000000356. ARTICLE NAME: HEARTWARE HVAD FOR BIVENTRICULAR SUPPORT IN CHILDREN AND ADOLESCENTS: THE STANFORD EXPERIENCE COMPUTED TOMOGRAPHY. BY: MAR Y LYN STEIN,* JUSTIN YEH,[?] OLAF REINHART Z,[?] DAVID N. ROSENTHAL,§ BETH D. KAUFMA N,§ CHRIS S. ALMOND,§ SETH A. HOLLANDER,§ AND KATSUHIDE MAEDA [?] THIS IS ONE OF FIVE MFR REPORTS (3007042319-2017-03103, 3007042319-2017-02971, 3007042319-2017-03116, 3007042319-2017-03141 AND 3007042319-2017-02949) SUBMITTED FOR THE SAME ARTICLE.

    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. RELATED MFR#'S: 3007042319-2017-03103, 3007042319-2017-02899, 3007042319-2017-03116. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER. 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. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING VENTRICULAR ASSIST DEVICES (VADS).  THE ARTICLE DISCUSSED VADS FOR BIVENTRICULAR SUPPORT IN CHILDREN AND ADOLESCENTS.  ONE PATIENT'S INTRAOPERATIVE COURSE OF IMPLANT OF LEFT AND RIGHT VENTRICULAR ASSIST DEVICES (VAD) WAS COMPLICATED BY HEMORRHAGE NECESSITATING TRANSFUSION OF MULTIPLE BLOOD PRODUCTS AND ANTI-INHIBITOR COAGULANT COMPLEX.  THE PATIENT WAS EXTUBATED ON POST-OP DAY (POD) 5.  THE PATIENT DEVELOPED TAMPONADE ON POD 10 AND UNDERWENT EMERGENT CHEST EXPLORATION AND EVACUATION OF HEMATOMA.  THEY HAD ONGOING RESPIRATORY FAILURE AND SYSTEMIC INFLAMMATION IN THE ABSENCE OF INFECTION, WITH FEVERS, ELEVATED WHITE BLOOD CELL COUNT AND ELEVATED C-REACTIVE PROTEIN (CRP).  IN ADDITION, DEMONSTRATED LOW SYSTEMIC VASCULAR RESISTANCE AND REQUIRED FREQUENT ADJUSTMENTS OF THEIR VAD SETTINGS, AS WELL AS, INITIATION OF ESMOLOL TO SLOW THEIR NATIVE HEART RATE AND OPTIMIZE VAD FILLING.  ON POD 13, THE PATIENT DEVELOPED VENTRICULAR TACHYCARDIA ASSOCIATED WITH DECREASED VAD FILLING NECESSITATING DEFIBRILLATION. LATER THE SAME DAY, THEY UNDERWENT DIAGNOSTIC CARDIAC CATHETERIZATION, WHICH REVEALED MODERATELY ELEVATED FILLING PRESSURES WHICH SHOWED MODERATE IMPROVEMENT WITH CHANGES IN VAD SETTINGS.  THEY WERE EXTUBATED TO BIPAP 5 DAYS FOLLOWING THE CATHETERIZATION (POD 18).  THE PATIENT UNDERWENT HEART TRANSPLANTATION ON DAY 22 OF VAD SUPPORT.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646433 HEARTWARE® VENTRICULAR ASSIST SYSTEM - UNK-PUMP CIRCULATORY ASSIST SYSTEM, DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| L| R