BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE VIABAHN® ENDOPROSTHESIS - 3

    MDR report key: 8078469 · Received November 16, 2018

    Report

    Report Number
    2017233-2018-00699
    Event Type
    Death
    Date Received
    November 16, 2018
    Date of Event
    October 22, 2017
    Report Date
    October 31, 2018
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    PFV
    PMA / PMN Number
    P130006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    WITHIN THE ARTICLE ¿MANAGEMENT OF CLINICALLY RELEVANT POSTPANCREATECTOMY HEMORRHAGE (PPH) OVER TWO DECADES - A COMPARATIVE STUDY OF 1450 CONSECUTIVE PATIENTS UNDERGOING PANCREATIC RESECTION¿, PUBLISHED BY STEFFEN WOLK ET AL, WITHIN THE PANCREATOLOGY, ACCEPTED FOR PUBLICATION ON OCTOBER 22, 2017, THE ARTICLE RESULTS INDICATE THE FOLLOWING: BETWEEN 1994 AND 2014 THE OCCURRENCE OF PPH IN 115 OUT OF 1450 PATIENTS FROM A PROSPECTIVELY COLLECTED DATABASE WAS ANALYZED. THE COHORT WAS DIVIDED INTO TWO TIME PERIODS: 1994 - 2009 AND 2010 - 2014. THE DIFFERENCES BETWEEN THE TWO GROUPS WERE ANALYZED. THE OBJECTIVE OF THE STUDY WAS THE OUTCOME AND MANAGEMENT OF PATIENTS AFTER PPH AND TO EVALUATE THE MANAGEMENT ALGORITHM FOR PPH IN TWO PERIODS OF TIME. DEPENDING ON THE ORIGIN OF HEMORRHAGE, PPH CAN BE TREATED NONSURGICALLY, ENDOSCOPICALLY, BY RELAPAROTOMY OR ANGIOGRAPHICALLY. IN THE SUBGROUP WITH GRADE C PPH IN THE PERIOD FROM 2010 TO 2014, 12 PATIENTS WERE TREATED WITH INTERVENTIONAL ANGIOGRAPHY. IN THIS GROUP, ONLY 3 OUT OF 12 PATIENTS SURVIVED. 6 OF THE 9 DECEASED PATIENTS WERE TREATED WITH STENT GRAFTS (GORE® VIABAHN® 5/50 MM IN 5 PATIENTS, GORE® VIABAHN® 6/50 MM IN 1 PATIENT), 2 PATIENTS RECEIVED COIL EMBOLIZATION AND 1 PATIENT RECEIVED AN UNSUCCESSFUL INTERVENTION. IN THE SUBGROUP OF PATIENTS WITH GRADE C PPH TREATED WITH INTERVENTIONAL ANGIOGRAPHY, IT SHOULD BE NOTED THAT THE MAIN CAUSE FOR THE HIGH CASE FATALITY WAS EARLY STENT THROMBOSIS WITH DEVELOPMENT OF LIVER ABSCESSES AND HEPATIC FAILURE, AND THAT NONE OF THE PATIENTS DIED IN SEVERE HEMORRHAGIC SHOCK. THEREFORE, THE AUTHORS BELIEVE THAT THESE PATIENTS COULD HAVE BEEN SAVED BY A MORE ACCURATE MANAGEMENT (E.G. ANTICOAGULATION MANAGEMENT). ANTICOAGULATION MANAGEMENT DEPENDS ON INTERVENTIONAL TREATMENT. AFTER STENT GRAFT PLACEMENT, COMBINED PLATELET FUNCTION INHIBITION WITH CLOPIDOGREL AND ASPIRIN IS REQUIRED TO PREVENT STENT GRAFT THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919229 GORE VIABAHN® ENDOPROSTHESIS - 3 NIP PFV W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death