BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 5064363 · Received September 9, 2015

    Report

    Report Number
    2029214-2015-00963
    Event Type
    Death
    Date Received
    September 9, 2015
    Date of Event
    August 6, 2015
    Report Date
    August 13, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OFF LABEL USE: THE PIPELINE EMBOLIZATION DEVICES WERE USED TO TREAT ANEURYSMS IN POSTERIOR COMMUNICATING ARTERY, ANTERIOR CEREBRAL ARTERY, BASILAR ARTERY, AND VERTEBRAL ARTERY. THE INSTRUCTION FOR USE STATED THAT THE PIPELINE¿ EMBOLIZATION DEVICE (PED) IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF ADULTS (22 YEARS OF AGE OR OLDER) WITH LARGE OR GIANT WIDE-NECKED INTRACRANIAL ANEURYSMS (IAS) IN THE INTERNAL CAROTID ARTERY FROM THE PETROUS TO THE SUPERIOR HYPOPHYSEAL SEGMENTS. 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. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE, BUT RATHER A PROCEDURE RELATED EVENT. INTRACEREBRAL BLEEDING IS A KNOWN ADVERSE EVENT RELATED TO THE FLOW DIVERSION PROCEDURE. REFER TO MDR #2029214-2015-00962 FOR THE SERIOUS ADVERSE EVENTS REPORTED IN THIS LITERATURE ARTICLE.

    Description of Event or Problem · 1

    MEDTRONIC (COVIDIEN) RECEIVED INFORMATION FROM LITERATURE REVIEW THAT 9 PATIENTS HAD INTRAPARENCHYMAL HEMORRHAGE (IPH) AND DIED POST-PIPELINE EMBOLIZATION DEVICE IMPLANTATION. THIS STUDY IS A SUBANALYSIS OF THE INTREPED STUDY; ITS PURPOSE IS TO EXAMINE THE CLINICAL AND PROCEDURAL CHARACTERISTICS ASSOCIATED WITH IPH AFTER PED IMPLANTATION. SEVEN HUNDRED NINETY-THREE PATIENTS TREATED FOR 906 ANEURYSMS WERE ENROLLED. TWENTY OF THE 793 PATIENTS HAD IPH; ALL TWENTY PATIENTS DEVELOPED IPH WITHIN 6 MONTHS POST-PROCEDURE. AMONG PATIENTS WITH IPH, 9 (45.0%) DIED. THIS STUDY CONCLUDED THAT VARIABLES ASSOCIATED WITH IPH INCLUDE USE OF MULTIPLE PEDS AND TREATMENT OF RUPTURED ANEURYSMS. ALSO, SINCE ALL IPHS OCCURRED WITHIN SIX MONTHS, IT SUGGESTS THAT USE OF ANTIPLATELET THERAPY IS A POTENTIAL RISK FACTOR. CITATION: BRINJIKJI W, LANZINO G, CLOFT HJ, ET AL. RISK FACTORS FOR HEMORRHAGIC COMPLICATIONS FOLLOWING PIPELINE EMBOLIZATION DEVICE TREATMENT OF INTRACRANIAL ANEURYSMS: RESULTS FROM THE INTERNATIONAL RETROSPECTIVE STUDY OF THE PIPELINE EMBOLIZATION DEVICE. AJNR AM J NEURORADIOL. 2015 AUG 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597109 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE) PIPELINE NI

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death