BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3911494 · Received May 28, 2014

    Report

    Report Number
    2916596-2014-00848
    Event Type
    Death
    Date Received
    May 28, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 28, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DIRECT RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED. THE CUSTOMER REPORTED THAT THE PATIENT HAD MEDIASTINAL BLEEDING AND HEMATURIA THAT BEGAN ON (B)(6) 2014. EAR, NOSE AND THROAT BLEEDING BEGAN ON (B)(6) 2014. NO SOURCE OF THE BLEEDING COULD BE FOUND. THE PATIENT WAS TREATED WITH PACKED RED BLOOD CELLS, AMPICILLIN AND NEXIUM. THE FAMILY ELECTED TO INITIATE COMFORT CARE. THE PATIENT WAS MADE DNR AND EXPIRED. THE PUMP WAS REPORTED TO HAVE BEEN OPERATING AS INTENDED AND THE EVENT WAS NOT BELIEVED TO BE DEVICE RELATED. THE PUMP WAS NOT EXPLANTED AND WAS NOT AVAILABLE FOR EVALUATION. THORATEC¿S APPROVED LABELING LISTS BLEEDING AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PUMP WILL NOT BE RETURNING TO THE MFR FOR EVAL, AS IT WAS NOT EXPLANTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2014. IT WAS REPORTED BY THE VAD ADMINISTRATOR THAT PRIOR TO IMPLANT THE PT WAS ADMITTED FROM AN OUTSIDE HOSPITAL ON (B)(6) 2014 FOR MANAGEMENT OF HEART FAILURE. ON (B)(6) 2014, ONE DAY POST IMPLANT, THE PT RECEIVED 10 UNITS OF PACKED RED BLOOD CELLS (PRBC) AND 8 UNITS OF FRESH FROZEN PLASMA (FFP). OVER THE COURSE OF THE NEXT FEW WEEKS THE PT RECEIVED MULTIPLE ADD'L TRANSFUSIONS OF PRBC AND FFP. ON (B)(6) 2014, CONTINUOUS BLADDER IRRIGATION (CBI) WAS INITIATED FOR HEMATURIA. ADDITIONALLY, A CLOT IN THE OROPHARYNX WAS NOTED, AND ON EXAM A SMALL AMOUNT OF BLOOD IN THE LEFT NARES WAS NOTED WHICH WAS PACKED WITH GAUZE. ON (B)(6) 2014, THE PT BECAME UNRESPONSIVE AND BRIEFLY APNEIC. THE PT WAS INTUBATED AND A TRACHEOSTOMY WAS PERFORMED AT A LATER UNSPECIFIED DATE. ON (B)(6) 2014, THE CBI WAS STOPPED BUT WAS RESTARTED DUE TO SEVERE HEMATURIA. ON (B)(6) 2014, A RENAL CONSULT FOR ACUTE KIDNEY INJURY (AKI) WAS CONDUCTED, AND ON (B)(6) 2014 A CT OF THE ABDOMEN/PELVIS SHOWED BILATERAL HYDRONEPHROSIS, AND CLOTS IN THE PT'S BLADDER. ON (B)(6) 2014, A CYSTOSCOPY WITH CLOT EVALUATION WAS PERFORMED, AND HEMODIALYSIS WAS STARTED. THE FOLLOWING DAY, THE PT EXPERIENCED UPPER GI BLEEDING. AN UPPER GI ENDOSCOPY WAS PERFORMED WHICH DID NOT SHOW THE SOURCE OF THE BLEEDING. A HEMATOLOGY CONSULT WAS REQUESTED FOR POSSIBLE HEPARIN INDUCED THROMBOCYTOPENIA (HIT). ON (B)(6) 2014, PER THE FAMILY'S WISHES, THE PT WAS MADE DNR, COMFORT CARE WAS INITIATED, AND THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314170 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 138088

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death