BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4197553 · Received October 23, 2014

    Report

    Report Number
    2029214-2014-00593
    Event Type
    Death
    Date Received
    October 23, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 23, 2014
    Manufacturer
    COVIDIEN
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT. THE OTHER DEVICE INVOLVED IN THE PROCEDURE IS AS FOLLOWS: MODEL: FA-71500-30 / LOT: 9937700 DOM: 10 JUL 2014 EXP: 10 JUL 2015. REFERENCE CER (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A LARGE UNRUPTURED ANEURYSM MEASURING 20MM X 16MM IN THE LATERAL VIEW AND 14MM X 14MM IN THE AP FRONTAL VIEW WITH A 4MM NECK. THE ANEURYSM WAS LOCATED IN THE CAVERNOUS SEGMENT OF THE RIGHT ICA (INTERNAL CAROTID ARTERY) AND EXTENDED INTO THE SPHENOID SINUS. THE ANEURYSM WAS DISCOVERED A FEW WEEKS PRIOR TO THE TREATMENT WHEN THE PATIENT PRESENTED WITH A TIA (TRANSIENT ISCHEMIC ATTACK). THE PATIENT HAS A FACTOR V ABNORMALITY AND IS HYPER-COAGULABLE. THE PATIENT WAS GIVEN COUMADIN AFTER THE TIA. PRIOR TO THE PIPELINE PROCEDURE, SHE WAS TAKEN OFF COUMADIN AND PLACED ON LOVENOX AND PLAVIX. HEPARIN WAS GIVEN INTRA-OPERATIVELY AND THE ACT (ACTIVATED CLOTTING TIME) WAS 2 ¿ 2.5 TIMES BASELINE PER THE MD DICTATION. THE PATIENT¿S ANATOMY WAS TORTUOUS. ON (B)(6) 2014, THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT INVOLVING THREE PIPELINES. DURING THE PROCEDURE, THE FIRST PIPELINE (5MM X 35MM) REQUIRED BALLOON ANGIOPLASTY (AN OPTION PRESENTED IN THE INSTRUCTIONS FOR USE, U.S.) TO ACHIEVE FULL WALL APPOSITION; HOWEVER, THE DEVICE FORESHORTENED CAUSING THE DISTAL END OF THE PIPELINE TO FALL INTO THE ANEURYSM. THE DISTAL END WAS REPOSITIONED ACROSS THE ANEURYSM NECK AND A SECOND PIPELINE (5MM X 16MM) WAS IMPLANTED FOLLOWED BY A THIRD PIPELINE (5MM X 30MM). ON (B)(6) 2014, THE PATIENT FELL AND WAS TRANSPORTED TO THE HOSPITAL WHERE THE PATIENT WAS DIAGNOSED WITH A MASSIVE FRONTAL IPSILATERAL PARENCHYMAL HEMORRHAGE AND EXPIRED THE SAME DAY. THE TREATING PHYSICIAN WAS UNSURE HOW THE PATIENT DEVELOPED THE IPSILATERAL PARENCHYMAL HEMORRHAGE; IF IT WAS DUE TO THE FALL, MEDICATIONS, OR FROM THE PIPELINE DEVICE OR PROCEDURE. SAME EVENT AS MDR# 2029214-2014-00592.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676504 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT COVIDIEN FA-77500-16 9834042

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death