BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4767176 · Received May 12, 2015

    Report

    Report Number
    2029214-2015-00548
    Event Type
    Death
    Date Received
    May 12, 2015
    Date of Event
    December 18, 2014
    Report Date
    April 20, 2015
    Manufacturer
    IRVINE
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE WEBSITE: HTTP://WWW.AJNR.ORG/CONTENT/36/4/725.LONG. THE INDICATION FOR USE FOR PIPELINE EMBOLIZATION DEVICE IN THE USA IS 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. THERE IS LIMITED INFORMATION ABOUT THE DEVICE AND/OR THE PATIENT, THEREFORE ALL REPORTED 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; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED. REFER TO MDR MFR# 2029214-2015-00547 FOR SERIOUS INJURIES AND MDR MFR# 2029214-2015-00546 FOR MALFUNCTION.

    Description of Event or Problem · 1

    MEDTRONIC (COVIDIEN) RECEIVED INFORMATION FROM THE LITERATURE THAT FIVE PATIENTS OUT OF 66 PATIENTS IN THE STUDY DIED FOLLOWING PLACEMENT OF THE PIPELINE EMBOLIZATION DEVICE IN THE TREATMENT OF INTRACRANIAL ANEURYSMS. TWO PATIENTS WITH BASILAR ARTERY ANEURYSM DIED POST PED PLACEMENT PROCEDURE: ONE PATIENT, IN UNCLEAR CIRCUMSTANCES, PROBABLY SECONDARY TO A DELAYED RUPTURE, AND THE SECOND FOLLOWING IN-STENT THROMBOSIS RELATED TO PREMATURE DISCONTINUATION OF ANTIPLATELET THERAPY. THREE PATIENTS DIED DURING FOLLOW-UP, AT DAYS 10, 15, AND 25. DEATHS WERE RELATED TO IN-STENT THROMBOSIS IN 1 CASE AND DELAYED ANEURYSM RUPTURE IN 2 CASES. DELAYED ANEURYSM RUPTURE OCCURRED IN AN (B)(6) WOMAN TREATED FOR A LARGE BASILAR ARTERY ANEURYSM IN 1 CASE AND A (B)(6) WOMAN TREATED FOR A LARGE CAROTICO-OPHTHALMIC ANEURYSM IN THE OTHER CASE. THIS RETROSPECTIVE STUDY GOAL WAS TO INVESTIGATE THE PATENCY OF COVERED SIDE BRANCHES AND FLOW MODIFICATION WITHIN THE PARENT ARTERY FOLLOWING PLACEMENT OF THE PIPELINE EMBOLIZATION DEVICE. SIXTY-SIX ANEURYSMS IN 59 PATIENTS WERE TREATED WITH 96 PIPELINE EMBOLIZATION DEVICES. THE STUDY GROUP WAS ALL CONSECUTIVE PATIENTS TREATED WITH THE PED FROM JULY 2009 TO JUNE 2012 IN 2 LARGE FRENCH NEUROSCIENCE CENTERS. CITATION: GASCOU G1, LOBOTESIS K2, BRUNEL H, ET AL. EXTRA-ANEURYSMAL FLOW MODIFICATION FOLLOWING PIPELINE EMBOLIZATION DEVICE IMPLANTATION: FOCUS ON REGIONAL BRANCHES, PERFORATORS, AND THE PARENT VESSEL. AJNR AM J NEURORADIOL. 2015 APR;36(4):725-31. DOI: 10.3174/AJNR.A4191.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310447 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT IRVINE

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death