BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3749658 · Received April 14, 2014

    Report

    Report Number
    2029214-2014-00223
    Event Type
    Death
    Date Received
    April 14, 2014
    Report Date
    March 24, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. (B)(4).

    Description of Event or Problem · 1

    LITERATURE ARTICLE RECEIVED: HU YC, M.D., DESHMUKH VR, M.D., ALBUQUERQUE FC, M.D., ET AL. HISTOPATHOLOGICAL ASSESSMENT OF FATAL IPSILATERAL INTRAPARENCHYMAL HEMORRHAGES AFTER THE TREATMENT OF SUPRACLINOID ANEURYSMS WITH THE PIPELINE EMBOLIZATION DEVICE. J NEUROSURG. 2014 FEB; VOLUME 120:365-374 THE ARTICLE INDICATED DELAYED IPSILATERAL INTRAPARENCHYMAL HEMORRHAGE WAS OBSERVED FOLLOWING TREATMENT WITH THE PED (PIPELINE EMBOLIZATION DEVICE). THE RELATIONSHIP OF THIS ADVERSE EVENT TO THE PIPELINE AND/OR PROCEDURE IS UNKNOWN. THREE PATIENTS WERE TREATED WITH PIPELINE EMBOLIZATION DEVICE AND ALL THREE PATIENTS WERE DISCHARGED HOME THE FOLLOWING DAY WITHOUT ANY NEUROLOGICAL DEFICITS. THE PATIENTS WERE ON 325 MG ASPIRIN AND 75 MG CLOPIDOGREL FOR 72 HOURS PRIOR TO THE PROCEDURE AND HEPARIN DURING THE PROCEDURE. IT WAS REPORTED THAT ALL THREE PATIENTS EXPIRED FROM A DELAYED IPSILATERAL IPH (INTRAPARENCHYMAL HEMORRHAGES) BETWEEN 3 TO 14 DAYS POST PROCEDURE. POSTMORTEM EXAM REVEALED THAT ALL THREE PATIENTS HAD A LARGE IPH IPSILATERAL TO THE IMPLANTED PED. IN ALL 3 CASES, THE TREATED ANEURYSM WAS INTACT WITH NO EVIDENCE OF HEMORRHAGE OR RUPTURE. MICROSCOPIC ANALYSIS REVEALED A FOREIGN BODY OCCLUDING SMALL VESSELS INSIDE THE AREA OF THE HEMORRHAGE IN THE PATIENTS AND FURTHER ANALYSIS USING FTIR (FOURIER TRANSFORM INFRARED) SPECTROSCOPY ON 2 OF THE 3 PATIENTS SHOWED THAT THE EMBOLIC MATERIAL WAS POLYVINYLPYRROLIDONE (PVP) AND WAS IDENTICAL TO THE COATING OF THE COOK SHUTTLE GUIDING SHEATHS. THE MATERIAL IS NOT USED IN MANUFACTURE OF THE PED ITSELF. EVEN THOUGH THE MATERIALS WERE IDENTICAL IN ALL THREE PATIENTS, THERE WAS NOT ENOUGH MATERIAL IN THE 3RD PATIENT FOR FTIR SPECTROSCOPY. IN ALL THREE CASES IT WAS CONFIRMED THAT A 6-F COOK SHUTTLE, A 0.035-IN GUIDEWIRE AND A 0.014-IN SYNCHRO MICROWIRE WERE ALL USED IN EACH OF THE PROCEDURES. THERE ARE VIDEOS THAT DEMONSTRATE 3 SEPARATE INSTANCES OF THE SLIP CATHETER BEING WITHDRAWN FROM THE COOK FLEXOR SHUTTLE SHEATH, RESULTING IN RESIDUE OF FOREIGN MATERIAL AT THE TIP OF THE SHUTTLE. IN THE FIRST TWO PATIENTS, THE MATERIAL WAS CONFIRMED TO BE IN THE TISSUES. CASE #1: TREATMENT OF AN ANEURYSM LOCATED IN THE PARA-OPHTHALMIC SEGMENT OF THE LEFT ICA (INTERNAL CAROTID ARTERY). PATIENT WAS TREATED SUCCESSFULLY WITH ONE PED (5.00MM X 20MM) AND WAS DISCHARGED HOME NEUROLOGICALLY INTACT ON THE FOLLOWING DAY. THREE DAYS AFTER THE PROCEDURE, THE PATIENT SUFFERED AN EPISODE OF SYNCOPE AND EXPIRED FROM A LARGE LEFT IPSILATERAL IPH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226533 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77500-20 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death