BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4356169 · Received December 23, 2014

    Report

    Report Number
    2029214-2014-00770
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    December 1, 2014
    Report Date
    December 1, 2014
    Manufacturer
    COVIDIEN
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORD OF THE REPORTED LOT NUMBER HAS BEEN REVIEWED AND NO ISSUES WERE NOTED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN ANEURYSM LOCATED IN THE OPHTHALMIC SEGMENT OF THE LEFT ICA (INTERNAL CAROTID ARTERY). THE PHYSICIAN STATED THAT THE PATIENT¿S ANATOMY WAS VERY TORTUOUS AND REACTIVE (OFTEN MEANS VASOSPASM TRIGGERED BY CONTACT/STIMULATION OF ACCESS DEVICES; HOWEVER, THE PHYSICIAN DID NOT EXACTLY SAY THAT VASOSPASM OCCURRED). THE PATIENT WAS FOUND UNRESPONSIVE TO PLAVIX AND BRILINTA. THE PATIENT WAS ON ASA AND PRASUGREL. ON (B)(6) 2014, THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT. DURING THE PROCEDURE, IT WAS REPORTED THE PIPELINE (4.75MM X 12MM) WAS NAVIGATED TO THE M1 SEGMENT AND UNSHEATHED. AT THAT POINT, THE PHYSICIAN STATED THE PIPELINE WAS NOT RESPONDING TO THE PUSHWIRE OR THE MICROCATHETER AND IT APPEARED TO NOT OPEN ON THE PROXIMAL END. THE PIPELINE WAS REMOVED BY TRAPPING THE BRAID BETWEEN THE CAPTURE COIL AND THE CATHETER. A SECOND PIPELINE (4.75MM X 12) WAS THEN PLACED WITH THE DISTAL EDGE IN THE P-COMM (POSTERIOR COMMUNICATING) ARTERY THIS TIME. THE PHYSICIAN WAS ABLE TO MANEUVER THE PIPELINE INTO PROPER POSITION RELATIVE TO ANEURYSM NECK. THE PIPELINE RELEASED FROM CAPTURE COIL, BUT THE PROXIMAL END WOULD NOT OPEN. AT SOME POINT, THE PUSHER WIRE BROKE OFF. THE PHYSICIAN WAS ABLE TO RETRIEVE THE PIPELINE WITH A SNARE AND THE CASE WAS ABORTED. THE PATIENT'S CONDITION WAS NOT DIRECTLY COMPROMISED. THERE WAS NO INJURY TO THE PATIENT AT THE TIME. THE FOLLOWING DAY ON (B)(6) 2014, THE PATIENT HAD A SECOND PROCEDURE. DURING THIS PROCEDURE, THE PIPELINE (4.75MM X 12) WOULD NOT RELEASE FROM THE CAPTURE COIL AND IT WAS REMOVED FROM THE PATIENT. ANOTHER PIPELINE WAS THEN SUCCESSFULLY IMPLANTED WITHOUT INCIDENT. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE. SAME EVENT AS MDR# 2029214-2014-00771 AND 2029214-2014-00772.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848648 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN FA-77475-12 9919725

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR