BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4762977 · Received May 11, 2015

    Report

    Report Number
    2029214-2015-00522
    Event Type
    Injury
    Date Received
    May 11, 2015
    Date of Event
    January 23, 2013
    Report Date
    April 13, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE WEBSITE: HTTP://JNIS.BMJ.COM/CONTENT/6/1/19.LONG OFF LABEL USE: PEDS WERE USED IN PATIENTS WITH PRE-EXISTING STENT. PER PED IFU CONTRAINDICATIONS: PATIENTS IN WHOM A PRE-EXISTING STENT IS IN PLACE IN THE PARENT ARTERY AT THE TARGET ANEURYSM LOCATION. THERE IS LIMITED INFORMATION ABOUT THE DEVICE AND/OR THE PATIENT, THEREFORE ALL SERIOUS ADVERSE 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. REFERENCE MDR 2029214-2015-00521 FOR DEVICE MALFUNCTION EVENTS FROM THE SAME ARTICLE.

    Description of Event or Problem · 1

    MEDTRONIC (COVIDIEN) RECEIVED INFORMATION FROM LITERATURE REVIEW THAT SERIOUS ADVERSE EVENTS AFTER FLOW DIVERSION TREATMENTS WITH PIPELINE EMBOLIZATION DEVICE PERFORMED IN 15 PATIENTS WERE REPORTED AS FOLLOWS: ONE PATIENT EXPERIENCED RIGHT-SIDED INSULAR INTRAPARENCHYMAL HEMORRHAGE; ONE PATIENT EXPERIENCED LEFT BASAL GANGLIA INFARCT; ONE PATIENT WHO REQUIRED BALLOON ANGIOPLASTY DURING THE PROCEDURE EXPERIENCED HEMIPARESIS AND BLURRY VISION; ONE PATIENT DEVELOPED CAROTID DISSECTION; ONE PATIENT HAD PED DID NOT FULLY EXPAND (40-50%) WITHIN THE PREVIOUSLY PLACED STENT DESPITE BALLOON ANGIOPLASTY AND THE PATIENT'S ANEURYSM REMAINED OPEN AT THE 3 MONTH FOLLOW UP. THIS RETROSPECTIVE STUDY INCLUDED FIFTEEN PATIENTS WITH RECURRENT INTRACRANIAL ANEURYSMS AFTER PREVIOUS EMBOLIZATION OR SURGICAL CLIPPING WHO WERE TREATED WITH THE PED AT ONE INSTITUTION BETWEEN 2011 AND 2012. OF THE 15 PATIENTS, 12 WERE WOMEN (80%) AND THREE WERE MEN (20%). THE MEAN AGE OF THE PATIENTS WAS 54 YEARS (RANGE 31¿80 YEARS).TREATMENT WAS SUCCESSFUL IN ALL 15 PATIENTS. CITATION: CHALOUHI N1, CHITALE R, STARKE RM, ET AL. TREATMENT OF RECURRENT INTRACRANIAL ANEURYSMS WITH THE PIPELINE EMBOLIZATION DEVICE. J NEUROINTERV SURG. 2014 JAN;6(1):19-23. DOI: 10.1136/NEURINTSURG-2012-010612.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307773 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention