BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4708688 · Received April 21, 2015

    Report

    Report Number
    2029214-2015-00404
    Event Type
    Death
    Date Received
    April 21, 2015
    Date of Event
    August 24, 2011
    Report Date
    March 23, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE WEBSITE: HTTP://LINK.SPRINGER.COM/ARTICLE/10.1007%2FS00234-011-0914-7?LI=TRUE#. OFF LABEL USE: PIPELINE PLACEMENT IS CONTRAINDICATED IN PATIENTS WHO HAVE NOT RECEIVED DUAL ANTIPLATELET AGENTS PRIOR TO THE PROCEDURE. THE AUTHOR REPORTED 2 PATIENTS WHO UNDERWENT THE PROCEDURE IN EMERGENCY WITHOUT DOUBLE ANTIPLATELET THERAPY AND PRESENTED WITH ACUTE (WITHIN 24 HRS) STENT THROMBOSIS, BOTH THE PATIENTS DIED FROM ISCHEMIC STROKE. THERE IS LIMITED INFORMATION ABOUT THE DEVICE AND/OR THE PATIENT, THEREFORE ALL DEATH EVENTS WERE CAPTURED IN THIS REPORT. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBERS WERE NOT REPORTED. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS AS THEY WERE IMPLANTED IN THE PATIENT; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED. RELATED MDR FROM THIS LITERATURE MDR 2029214-2015-00400 FOR SERIOUS INJURY AND 2029214-2015-00336 FOR DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    MEDTRONIC (COVIDIEN) RECEIVED INFORMATION FROM LITERATURE CITED THAT FOUR PATIENTS DIED POST PIPELINE EMBOLIZATION DEVICE PLACEMENT PROCEDURES IN THEIR STUDY. THE AUTHORS REPORTED THAT SIXTY-THREE PATIENTS (52 FEMALE, 11 MALES), MEAN AGE 51 YEARS (27-75) WERE TREATED BETWEEN NOV 2008 AND FEB 2011. SEVENTY-ONE ENDOVASCULAR PROCEDURES FOR A TOTAL OF 73 INTRACRANIAL ANEURYSMS WERE PERFORMED. THE PROCEDURE WAS ELECTIVE IN ALL PATIENTS EXCEPT 2 PRESENTED WITH SUBARACHNOID HEMORRHAGE AND TREATED IN EMERGENCY AND ONLY RECEIVED CLOPIDOGREL LOADING DOSE OF 600 MG BEFORE THE PROCEDURE. THESE 2 PATIENTS WHO UNDERWENT THE PROCEDURE IN EMERGENCY WITHOUT DOUBLE ANTIPLATELET THERAPY WERE PRESENTED WITH ACUTE (WITHIN 24 HRS) STENT THROMBOSIS, BOTH THE PATIENTS DIED FROM ISCHEMIC STROKE. DOUBLE ANTIPLATELET THERAPY (ASPIRIN 300 MG AND TYCLOPIDINE 250 MGX2) WAS DONE 5 DAYS BEFORE THE PROCEDURE. ONE PATIENT HAD AN HEMORRHAGIC EVENT AT 24 HOURS AND DIED. ANOTHER PATIENT PRESENTED AN INTRAPROCEDURAL THROMBOTIC COMPLICATION WITH DISTAL EMBOLIZATION AND DIED. CITATION: A. PAOLUCCI, V. CIVELLI, R. PAPA, M. ISALBERTI. PRELIMINARY RESULTS IN 63 CONSECUTIVE PATIENTS TREATED FOR INTRACRANIAL ANEURYSMS USING FLOW-DIVERTING STENTS (PIPELINE EMBOLIZATION DEVICE. NEURORADIOLOGY (2011) 53 (SUPPL 1):S1-S71. (HTTP://LINK.SPRINGER.COM/ARTICLE/10.1007%2FS00234-011-0914-7?LI=TRUE#).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263392 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death