BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4520761 · Received February 17, 2015

    Report

    Report Number
    2029214-2015-00155
    Event Type
    Injury
    Date Received
    February 17, 2015
    Date of Event
    April 18, 2014
    Report Date
    January 21, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE WEBSITE: HTTP://WWW.SCIENCEDIRECT.COM/SCIENCE/ARTICLE/PII/S0303846714001346. 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. (B)(4).

    Description of Event or Problem · 1

    CITATION: ZANATY ET AL. DEVELOPMENT OF NORMAL PRESSURE HYDROCEPHALUS AFTER THE PLACEMENT OF A PIPELINE EMBOLIZATION DEVICE FOR THE TREATMENT OF A LARGE ANEURYSM: CASE REPORT. CLINICAL NEUROLOGY AND NEUROSURGERY 122(2014)116-119. COVIDIEN RECEIVED INFORMATION THROUGH LITERATURE REVIEW THAT A PATIENT DEVELOPED A NORMAL PRESSURE HYDROCEPHALUS (NPH) AFTER THE PLACEMENT OF A PIPELINE EMBOLIZATION DEVICE (PED). IT WAS REPORTED THAT THE PATIENT WAS A (B)(6) YEAR OLD FEMALE WHO HAD AN UNEVENTFUL PED PLACEMENT TWO AND A HALF MONTHS PRIOR TO THE EVENT TO TREAT A RIGHT POSTERIOR-COMMUNICATING ARTERY (PCOM) ANEURYSM. THE PATIENT WAS DISCHARGED IN STABLE CONDITION THE DAF AFTER THE PROCEDURE AND WAS KEPT ON DUAL ANTIPLATELET THERAPY (DAPT) CONSISTING OF ASPIRIN (81 MG) AND CLOPIDOGREL (75 MG). TWO WEEKS PRIOR TO THE EVENT PATIENT WAS COMPLAINING OF PERSISTENT HEADACHES AND CHRONIC THIRD-NERVE PALSY. AN MRI WAS ORDERED AND WAS UNCHANGED FROM BASELINE. AN ANGIOGRAM SHOWED 100% THROMBOSIS OF THE ANEURYSM. THE PATIENT WAS PRESCRIBED STEROIDS AND WAS ASKED TO FOLLOW UP IN CLINICS. ON THE DAY OF THE EVENT, THE PATIENT STARTED HAVING DIFFICULTY AMBULATING, WITH SHUFFLING GAIT AND WAS EVEN UNABLE TO WALK ON HER OWN, IN ADDITION SHE WAS COMPLAINING OF URINARY INCONTINENCE AND WORSENING SHORT-TERM MEMORY LOSS. A HEAD CT SCAN WAS PERFORMED AND SHOWED MILD INCREASE IN SIZE OF THE VENTRICLES COMPARED TO THE IMMEDIATE POST-OPERATIVE CT. THE PATIENT WAS DIAGNOSED WITH NPH. THE PATIENT WAS MAINTAINED ON 81 MG OF ASPIRIN WHILE CLOPIDOGREL WAS DISCONTINUED FOR 5 DAYS. THE PATIENT THEN UNDERWENT A STANDARD VENTRICULOPERITONEAL SHUNT PLACEMENT. THE POST-OP CT SCAN SHOWED A SMALL AMOUNT OF INTRA VENTRICULAR HEMORRHAGE WITHOUT ANY CLINICAL SIGNIFICANCE. SHE RECOVERED FROM SURGERY WITHOUT ANY COMPLICATIONS AND WAS DISCHARGED HOME AFTER THREE DAYS IN STABLE CONDITION. SHE WAS KEPT ON 81 MG OF ASPIRIN AND PLAVIX WAS RESTARTED 48 H POST OPERATIVELY. ON 2-MONTH FOLLOW UP VISIT, THE PATIENT WAS WALKING INDEPENDENTLY WITHOUT ANY SHUFFLING, SHE WAS NO MORE HAVING ANY URINARY PROBLEMS AND HER SHORT MEMORY WAS STILL IMPROVING SLOWLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112791 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other| R