BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3891223 · Received June 11, 2014

    Report

    Report Number
    2916596-2014-00953
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    August 6, 2010
    Report Date
    May 13, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: JENNINGS D. L., WILLIAMS, C.T., MORGAN J. A.; PENTOXIFYLLINE FOR THE TREATMENT OF HEMOLYTIC ANEMIA IN A PATIENT WHO DEVELOPED RECURRENT GASTROINTESTINAL BLEEDING WHILE ON CONTINUOUS-FLOW LEFT VENTRICULAR ASSIST DEVICE SUPPORT; AMERICAN SOCIETY FOR ARTIFICIAL INTERNAL ORGANS JOURNAL 2013; 59:526-527. THE DATE OF THE EVENT IS AN ESTIMATED EVENT DATE PER THE ARTICLE INFO. IMPLANT DATE WAS (B)(6) 2010 PER THE HOSPITAL'S VAD COORDINATOR. EXPLANT DATE WAS (B)(6) 2012 PER THE HOSPITAL'S VAD COORDINATOR. THE PUMP WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE FOLLOWING EVENT WAS NOTED IN A PUBLISHED JOURNAL ARTICLE. A 64 YEAR OLD UNDERWENT IMPLANTATION OF A LEFT VENTRICULAR ASSIST DEVICE (LVAD) AS A BRIDGE TO TRANSPLANT FOR END-STAGE ISCHEMIC CARDIOMYOPATHY ON AUGUST 6, 2010. HER POSTOPERATIVE COURSE WAS COMPLICATED BY RECURRENT GASTROINTESTINAL BLEEDING (GIB) SECONDARY TO ARTERIOVENOUS MALFORMATIONS. TO REDUCE HER BLEEDING RISK, ASPIRIN WAS DISCONTINUED. HOWEVER, DUE TO HER HISTORY OF CARDIOEMBOLIC STROKE, WARFARIN THERAPY WITH AN INTERNATIONAL NORMALIZED RATIO GOAL OF 2-3 WAS CONTINUED. ON SEPTEMBER 29, 2011, SHE PRESENTED WITH ACUTE ANEMIA (HEMOGLOBIN OF 7.2 MG/DL) AND SIGNS OF ANOTHER GIB. SHE WAS TRANSFUSED TWO UNITS OF PACKED RED BLOOD CELLS AND DISCHARGED WITH HEMOGLOBIN OF 9.1 MG/DL. HER LACTATE DEHYDROGENASE (LDH) WAS 443 IU/L AT THAT TIME, AND HER HAPTOGLOBIN WAS UNDETECTABLE. THREE WEEKS LATER, SHE WAS READMITTED WITH HEMOGLOBIN OF 6.6 MG/DL WITHOUT ANY IDENTIFIABLE SOURCES OF BLEEDING. HER LDH WAS 936 IU/L, AND THE PERIPHERAL SMEAR REVEALED SCHISTOCYTES, CONSISTENT WITH SEVERE HEMOLYSIS. THERE WERE NO ALTERNATIVE ETIOLOGIES FOR THE ELEVATED LDH. THE PATIENT'S DEVICE SETTINGS WERE NORMAL, AND THERE WAS NO CLINICAL EVIDENCE OF DEVICE THROMBOSIS. A TRANSTHORACIC ECHO DID NOT REVEAL ANY FINDINGS SUGGESTIVE OF DEVICE MALFUNCTION; THE PATIENT'S LEFT VENTRICULAR END-DIASTOLIC DIAMETER WAS UNCHANGED FROM PREVIOUS REPORTS, AND THE INFLOW AND OUTFLOW VELOCITIES WERE EQUAL AT 0.8 M/SEC. GIVEN THE EVIDENCE OF HEMOLYTIC ANEMIA AND HER POOR CANDIDACY FOR ANTIPLATELET THERAPY SECONDARY TO RECURRENT BLEEDING, SHE WAS DISCHARGED ON PENTOXIFYLLINE 400 MG THRICE DAILY ON OCTOBER 27, 2011, WITH HEMOGLOBIN OF 11.2 MG/DL (AFTER FOUR UNITS OF PACKED RED BLOOD CELL TRANSFUSION). AFTER 60 DAYS OF PENTOXIFYLLINE THERAPY, HER HEMOGLOBIN REMAINED STABLE AT 10.0 MG/DL AND HER LDH WAS REDUCED TO 223 IU/L. ON JANUARY 3, 2012, SHE WAS READMITTED WITH ANOTHER GIB AND HEMOGLOBIN 6.6 MG/DL. HOWEVER, HER LDH REMAINED LOW AT 219 IU/L, WHICH SUGGESTED THAT HER HEMOLYSIS REMAINED SUPPRESSED. THE PATIENT CONTINUED ON SUCCESSFUL DEVICE SUPPORT UNTIL HER HEART TRANSPLANT ON JUNE 11, 2011. THERE WAS NO VISUAL EVIDENCE OF DEVICE THROMBOSIS UPON EXPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345631 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 109876

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention