BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4513756 · Received February 12, 2015

    Report

    Report Number
    2029214-2015-00120
    Event Type
    Injury
    Date Received
    February 12, 2015
    Date of Event
    August 21, 2014
    Report Date
    January 13, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.THERE IS LIMITED INFORMATION ABOUT THE DEVICE AND/OR THE PATIENT, THEREFORE ALL SERIOUS ADVERSE EVENTS WERE CAPTURED IN THIS REPORT. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. (B)(4).DEVICE MALFUNCTION FROM THIS LITERATURE WAS REPORTED IN MFR# 2029214-2015-00120.

    Description of Event or Problem · 1

    CITATION: TANWEER ET AL. CAVERNOUS CAROTID ANEURYSMS IN THE ERA OF FLOW DIVERSION: A NEED TO REVISIT TREATMENT PARADIGMS. AM J NEURORADIOL 35:2334-40. COVIDIEN RECEIVED INFORMATION THROUGH LITERATURE REVIEW AND THE FOLLOWING EVENTS WERE CAPTURED AS A RESULT OF THIS REVIEW: 41 PATIENTS WITH A CAVERNOUS CAROTID ANEURYSMS (CCA) WERE TREATED WITH A PIPELINE EMBOLIZATION DEVICE (PED) (MEAN AGE 57, 36 FEMALES, MEAN RADIOGRAPHIC FOLLOW-UP WAS 2 YEAR). (1) AN INTRAOPERATIVE IPSILATERAL SUBARACHNOID HEMORRHAGE WAS ENCOUNTERED BY 1 PATIENT WHICH WAS LIKELY THE RESULT OF A WIRE PERFORATION DURING AN EXCHANGE TECHNIQUE TO BYPASS THE ANEURYSM NECK. (2) IN-STENT STENOSIS 50% WAS FOUND IN 3/43 PATIENTS AT 6M AND AN ADDITIONAL CASE OF STENOSIS WAS FOUND AT 1Y. ALL CASES WERE ASYMPTOMATIC COMPLETE OCCLUSION OF THE PARENT VESSEL ALONG WITH THE ANEURYSM. (3) THREE CASES OF TRANSIENT NEUROLOGIC DEFICITS WERE ENCOUNTERED, 1 OF WHICH WAS A SMALL IPSILATERAL FRONTAL HEMATOMA AT POD3. (4) ONE CASE OF CAROTID-CAVERNOUS FISTULA WAS FOUND ON 6M FOLLOW-UP PRESENTING AT POD1 AS TINNITUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104472 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R| S