BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5528425 · Received March 28, 2016

    Report

    Report Number
    3007042319-2016-01354
    Event Type
    Injury
    Date Received
    March 28, 2016
    Date of Event
    February 28, 2016
    Report Date
    March 7, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE SYSTEM IS DESIGNED TO ASSIST A WEAKENED, POORLY FUNCTIONING LEFT VENTRICLE. THE IMPLANTATION OF A VAD IS AN INVASIVE PROCEDURE REQUIRING GENERAL ANESTHESIA, MEDIAN STERNOTOMY, A VENTILATOR AND CARDIOPULMONARY BYPASS. THESE SURGICAL PROCEDURES ARE ASSOCIATED WITH NUMEROUS RISKS. BLEEDING IS A POTENTIAL EVENT THAT MAY BE ASSOCIATED WITH USE OF THE PRODUCT. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL PROVIDE GUIDELINES ON PROPER USAGE OF THE HVAD SYSTEM AND PROGRAMMING HVAD PUMP PARAMETERS. MOREOVER, THE IFU PROVIDES INSTRUCTION TO FURTHER EDUCATE THE PATIENT ABOUT PRODUCT SAFETY, ALARM MANAGEMENT, AND ANTICOAGULATION RECOMMENDATIONS. THE INSTRUCTIONS FOR USE (IFU) ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT INCLUDING HAVING ADEQUATE AND STABLE PRELOAD AVAILABLE. A REVIEW OF THE AVAILABLE INFORMATION DOES NOT INDICATE ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES THAT WOULD IMPACT THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED INCLUDE THE PATIENT'S UNIQUE ANATOMY, AND RELATED COMORBITIES. THERE ARE PATIENT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PERFUSIONIST THAT THE PATIENT WAS IN EMERGENCY ROOM DUE TO DOBHOFF TUBE COMING OUT AND REQUIRED REINSERTION WHICH THEN RESULTED IN EPITAXIS. RHINOROCKET INSERTED INTO LEFT NARE ON (B)(6) 2016. HGB 10.1 G/DL (NL 13-17), HCT 34.1 % ( NL 39-51), PLTS 258 K/MCL (NL 140-450), PT/INR 34.6/3.3 SECONDS (NL 9.7-11.6), PTT 49 SECONDS (NL 22-30). THE PATIENT WAS ON ASPIRIN AND COUMADIN AT TIME OF BLEED. COUMADIN PLACED ON HOLD ON (B)(6) 2016. THE PATIENT RECEIVED TOTAL OF 4 UNITS OF PACKED READ BLOOD CELLS. EAR, NOSE AND THROAT TEAM SAW THE PATIENT ON (B)(6) 2016 AND REMOVED LARGE CLOT FROM OROPHARYNX AND ON INSPECTION OOZING WAS PERSISTENT FROM OROPHARYNX. RHINO ROCKET REMOVED AND AN EPISTAT BALLOON WAS PLACE IN LEFT NASAL CAVITY DUE TO BLEEDING POSTERIOR. PACKING LEFT IN PLACE FOR 48-72 HOURS UNTIL COAGULOPATHY CORRECTS ITSELF. (B)(6) 2016, THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR REMOVAL OF EPISTAT BALLOON AND ENDOSCOPE WAS USED TO VISUALIZE THE LEFT NASAL CAVITY. THE NASAL CAVITY WAS FILLED WITH CLOT AND EVACUATED. SITE OF BLEEDING WAS IDENTIFIED AND CAUTERIZED. THE PATIENT WAS GIVEN TWO UNITS OF FFP IN THE OPERATING ROOM TO CORRECT COAGULOPATHY. BLEEDING WAS CONTROLLED AND HEMOSTASIS ACHIEVED BEFORE LEAVING THE OPERATING ROOM ON (B)(6) 2016 HGB 8.3 G/DL, HCT 26.6%, PLTS 383 K/MCL, PT/INR 29.4/2.8 SECONDS, PTT 45 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184297 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Life Threatening