BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE FLEX EMBOLIZATION DEVICE

    MDR report key: 5096550 · Received September 23, 2015

    Report

    Report Number
    2029214-2015-05008
    Event Type
    Death
    Date Received
    September 23, 2015
    Date of Event
    August 28, 2015
    Report Date
    August 28, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICE DURING USE. THE EVENTS OCCURRED IN THE PATIENT POST PROCEDURE AND THEIR CAUSES WERE UNKNOWN. PER INSTRUCTION FOR USE: CAUTION: PLACEMENT OF MULTIPLE PIPELINE¿ FLEX EMBOLIZATION DEVICES MAY INCREASE THE RISK OF ISCHEMIC COMPLICATIONS. SAME EVENT AS REPORTED IN MDR# 2029214-2015-05007. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC (COVIDIEN) RECEIVED REPORT THAT A PATIENT EXPERIENCED STROKE AND PASSED AWAY AFTER PIPELINE FLEX IMPLANTATION. THE PATIENT RECEIVED TWO OVERLAPPING PIPELINE FLEX (PED-350-14 AND PED-425-16) IMPLANTS TO TREAT A LARGE ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY (ICA). THERE WERE NO PROCEDURAL COMPLICATIONS OBSERVED. P2Y12 TESTING WAS DONE PRIOR TO THE PROCEDURE; PLATELET AGGREGATION WAS REPORTEDLY ACCEPTABLE THOUGH THE EXACT P2Y12 REACTION UNITS (PRU) LEVEL WAS NOT REPORTED. APPOSITION OF THE DEVICES WAS CONFIRMED VIA A DYNA CT AFTER THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT WAS COMPLIANT TO A DUAL ANTIPLATELET REGIMEN OF 75MG CLOPIDOGREL AND 325MG ASPIRIN. THREE DAYS POST-PROCEDURE, THE PHYSICIAN REPORTED THAT THE PATIENT WOKE UP WITH WEAKNESS AND WAS NOT OVERLY ALERT. AN MRI WAS PERFORMED LATER THAT DAY AND REVEALED A HOLOHEMISPHERIC STROKE WITH THE MIDDLE CEREBRAL ARTERY (MCA) AND STENT COMPLETELY OCCLUDED. THE PATIENT PASSED AWAY THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627744 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE) PED-425-16 A052287

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Death