BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4614610 · Received March 18, 2015

    Report

    Report Number
    2029214-2015-00266
    Event Type
    Malfunction
    Date Received
    March 18, 2015
    Date of Event
    February 20, 2015
    Report Date
    February 20, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORD REVIEW OF THE REPORTED LOT NUMBERS SHOWED NO DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EXPERIENCE. THE DEVICES WERE NOT RETURNED FOR ANALYSIS; THEREFORE, THE COMPLAINTS COULD NOT BE CONFIRMED, AND THE EVENT CAUSES COULD NOT BE DETERMINED. SAME EVENT AS REPORTED IN MDR MFR# 2029214-2015-00266, 2029214-2015-00267, 2029214-2015-00268, 2029214-2015-00269. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC (COVIDIEN) RECEIVED INFORMATION THAT DURING A FLOW DIVERSION TREATMENT OF A RIGHT CAVERNOUS INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH 4 TELESCOPING PIPELINE EMBOLIZATION DEVICES (PEDS), A BALLOON ANGIOPLASTY WAS REQUIRED TO OPEN THE DEVICES DUE TO SLOW RIGHT ICA FLOW AFTER DELIVERY OF THE 4 PEDS (MDR MFR# 2029214-2015-00266, MDR MFR# 2029214-2015-00267, MDR MFR# 2029214-2015-00268, MDR MFR# 2029214-2015-00269). IT WAS REPORTED THAT THE VESSEL MEASUREMENTS FROM PRIOR CT IMAGING INDICATED A PROXIMAL VESSEL DIAMETER OF 4.7 MM; HOWEVER, THE ANEURYSM SIZE, NECK WIDTH, AND DISTAL VESSEL DIAMETERS ARE UNKNOWN, AS MEASUREMENTS WERE NOT TAKEN DUE TO TECHNICAL DIFFICULTIES ENCOUNTERED WITH THE IMAGING EQUIPMENT DURING THE CASE. ABCIXIMAB WAS ADMINISTERED INTRAVENOUSLY FOLLOWING IMPLANTATION. IT WAS REPORTED THAT A BALLOON CATHETER WAS USED TO PERFORM ANGIOPLASTY FROM THE PROXIMAL TO DISTAL ASPECTS OF THE 4 DEVICE CONSTRUCTS. THE FLOW IMPROVED IMMEDIATELY FOLLOWING ADMINISTRATION OF ABCIXIMAB AND BALLOON ANGIOPLASTY OF THE DEVICES. THERE ARE NO SAMPLES TO RETURN AS THEY WERE ALL IMPLANTED. THE PATIENT WAS NOT HARMED DURING THE PROCEDURE, AND WAS DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184915 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE) FA-71475-35 9957563

    Patients

    Seq Age Sex Outcome Treatment
    1