BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3870299 · Received June 12, 2014

    Report

    Report Number
    3007042319-2014-00609
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 15, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) GI BLEEDING. THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE TREATING FACILITY WITH LETHARGY, PALLOR AND PROBABLE MELENA. PATIENT WAS TREATED WITH BLOOD TRANSFUSIONS AND AN ENDOSCOPY. PROCEDURES DID NOT IDENTIFY ANY SOURCE OF ACTIVE BLEEDING AND SUSPECTED DIAGNOSIS WAS ARTERIOVENOUS MALFORMATION. THE PATIENT REMAINED IN THE HOSPITAL REQUIRING FURTHER BLOOD TRANSFUSIONS AND A HEPARIN INFUSION AND WAS DISCHARGED FOUR DAYS LATER. GASTROINTESTINAL BLEEDING AND ARTERIOVENOUS MALFORMATIONS HAVE BEEN IDENTIFIED AS A KNOWN POTENTIAL RISK ASSOCIATED WITH USE OF ALL VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). ALTHOUGH THIS EVENT IS LIKELY RELATED TO THE DEVICE SUPPORT AND REQUIRED ANTICOAGULANT THERAPY, THERE IS NO EVIDENCE TO SUGGEST A RELATIONSHIP TO ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES. KNOWN CONTRIBUTING FACTORS TO GI BLEEDING INCLUDE INDIVIDUAL PATIENT COMORBIDITIES AND PHARMACOLOGICAL FACTORS. THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT, INCLUDING THERAPEUTIC ANTICOAGULATION GUIDELINES. 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, INCLUDING TRANSPORTATION. GASTROINTESTINAL BLEEDING HAS BEEN IDENTIFIED AS A KNOWN POTENTIAL RISK ASSOCIATED WITH USE OF ALL VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). ALTHOUGH THIS EVENT IS LIKELY RELATED TO THE DEVICE SUPPORT AND REQUIRED ANTICOAGULANT THERAPY, THERE IS NO EVIDENCE TO SUGGEST A RELATIONSHIP TO ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES. KNOWN CONTRIBUTING FACTORS TO GI BLEEDING INCLUDE INDIVIDUAL PATIENT COMORBIDITIES AND PHARMACOLOGICAL FACTORS. THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT, INCLUDING THERAPEUTIC ANTICOAGULATION GUIDELINES. HEARTWARE IS SUBMITTING THIS 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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED IN THE PATIENT, THEREFORE IT WILL NOT BE RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AFTER ALMOST THREE MONTHS ON HEARTWARE SYSTEM SUPPORT, THIS PATIENT WAS ADMITTED TO HOSPITAL WITH LETHARGY, PALLOR AND PROBABLE MELENA. INR HAD MEASURED ABOVE THE THERAPEUTIC RANGE ONE WEEK PRIOR AND ON ADMISSION THERE WAS A DROP IN HEMOGLOBIN. HE WAS TREATED WITH A BLOOD TRANSFUSION (3 UNITS PRBCS) AND THREE DAYS LATER UNDERWENT ENDOSCOPY. ALTHOUGH THESE PROCEDURES DID NOT IDENTIFY ANY SOURCES OF ACTIVE BLEEDING, THE SUSPECTED DIAGNOSIS WAS ARTERIOVENOUS MALFORMATION. THE PATIENT REMAINED IN HOSPITAL, REQUIRING FURTHER BLOOD PRODUCTS (2 UNITS PRBCS) AND A HEPARIN INFUSION (INR 1.4), AND WAS DISCHARGED FOUR DAYS LATER. HE WAS REVIEWED AS AN OUTPATIENT TWO WEEKS FOLLOWING DISCHARGE AND MORE BLOOD PRODUCTS WERE ADMINISTERED (2 UNITS PRBCS OUTPATIENT) IN RESPONSE TO LOW HEMOGLOBIN. PILLCAM CAPSULE ENDOSCOPY WAS ALSO UNDER CONSIDERATION. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347421 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R