BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4869254 · Received June 25, 2015

    Report

    Report Number
    2029214-2015-00731
    Event Type
    Injury
    Date Received
    June 25, 2015
    Date of Event
    June 3, 2015
    Report Date
    June 8, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE WEBSITE; HTTP://JNIS.BMJ.COM/CONTENT/EARLY/2015/06/03/NEURINTSURG-2015-011672.LONG. OFF LABEL USE: PIPELINE EMBOLIZATION DEVICE (PED) IS CONTRAINDICATED IN PATIENTS IN WHOM A PRE-EXISTING STENT IS IN PLACE IN THE PARENT ARTERY AT THE TARGET ANEURYSM LOCATION. IN THIS STUDY, THE PED WAS USED IN AN OFF-LABEL MANNER IN PATIENTS WITH PRE-EXISTING NITINOL SELF-EXPANDING STENTS. OFF LABEL USE; PED IS CONTRAINDICATED IN PATIENTS IN WHOM DUAL ANTIPLATELET THERAPY (ASPIRIN AND CLOPIDOGREL) IS CONTRAINDICATED. THE LOT HISTORY RECORD REVIEWS WERE NOT POSSIBLE SINCE THE LOT NUMBERS WERE NOT REPORTED. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS AS THEY WERE IMPLANTED IN THE PATIENTS; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED. THERE IS LIMITED INFORMATION ABOUT THE DEVICE AND/OR THE PATIENT, THEREFORE ALL SERIOUS ADVERSE EVENTS WERE CAPTURED IN THIS REPORT. DEVICE MALFUNCTION EVENT FROM THE SAME ARTICLE WAS REPORTED IN MDR MFR# 2029214-2015-00731. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC (COVIDIEN) RECEIVED INFORMATION FROM LITERATURE REVIEW THAT SERIOUS ADVERSE EVENTS BELOW OCCUR DURING A STUDY OF USING FLOW-DIVERTING STENTS IN THE REPAIR OF 25 ANEURYSMS FOR WHICH STENT-ASSISTED EMBOLIZATION HAD FAILED: (1) ONE PATIENT WITH A RIGHT OPHTHALMIC ANEURYSM DEVELOPED A CAROTID-CAVERNOUS FISTULA AND AN OCULOMOTOR NERVE PALSY WITHIN 24 H OF PED DEPLOYMENT. THIS WAS IMMEDIATELY EMBOLIZED WITH LIQUID EMBOLIC AGENT AND THE PATIENT'S SYMPTOMS RESOLVED. (2) OVER 2 MONTHS AFTER PED PLACEMENT, A PATIENT WHO WAS NON-COMPLIANT WITH CLOPIDOGREL USE, WITH A LARGE LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM (12MMX19MM), DEVELOPED MILD RIGHT-SIDED WEAKNESS AND NUMBNESS, WHICH RESOLVED AFTER RESTARTING AN APPROPRIATE ANTIPLATELET AGENT REGIMEN. (3) AT 12-MONTH FOLLOW-UP, ONE PATIENT HAD RAYMOND CLASS III ANEURYSM OCCLUSION. THIS PATIENT WHO HAD A GIANT RIGHT CAVERNOUS FUSIFORM ANEURYSM DEMONSTRATED THAT THE PED WAS NOT COMPLETELY APPOSED PROXIMALLY AGAINST THE VESSEL WALL, RESULTING IN AN ENDOLEAK. THIS PATIENT HAD REQUIRED BALLOON ANGIOPLASTY OF A NARROWED PED SEGMENT AT THE TIME OF INITIAL RE-TREATMENT. CITATION: HEIFERMAN DM, BILLINGSLEY JT, KASLIWAL MK, ET AL. USE OF FLOW-DIVERTING STENTS AS SALVAGE TREATMENT FOLLOWING FAILED STENT-ASSISTED EMBOLIZATION OF INTRACRANIAL ANEURYSMS.J NEUROINTERV SURG. 2015 JUN 3. PII: NEURINTSURG-2015-011672.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413168 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention