BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOL. DEVICE 5.00MM X 25MM

    MDR report key: 5077968 · Received September 15, 2015

    Report

    Report Number
    2029214-2015-05000
    Event Type
    Death
    Date Received
    September 15, 2015
    Date of Event
    August 28, 2015
    Report Date
    August 29, 2015
    Manufacturer
    MEDTRONIC COVIDIEN
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS CORRECTION: AS PER, THE PIPELINE¿ EMBOLIZATION DEVICE (PED) IFU, THE PIPELINE EMBOLIZATION DEVICE IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF ADULTS (22 YEARS OF AGE OR OLDER) WITH LARGE OR GIANT WIDE-NECKED INTRACRANIAL ANEURYSMS (IAS) IN THE INTERNAL CAROTID ARTERY FROM THE PETROUS TO THE SUPERIOR HYPOPHYSEAL SEGMENTS.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). PATIENT'S HOME OFF LABEL USE: THE PIPELINE FLEX WAS USED TO TREAT BASILAR ARTERY ANEURYSM. PER PIPELINE FLEX INSTRUCTION FOR USE (IFU), THE PIPELINE¿ FLEX EMBOLIZATION DEVICE IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF ADULTS ((B)(6)) YEARS OF AGE OR OLDER) WITH LARGE OR GIANT WIDE-NECKED INTRACRANIAL ANEURYSMS (IAS) IN THE INTERNAL CAROTID ARTERY FROM THE PETROUS TO THE SUPERIOR HYPOPHYSEAL SEGMENTS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS IMPLANTED IN THE PATIENT AND NO AUTOPSY WILL BE PERFORMED; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE, BUT RATHER A PROCEDURE RELATED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE ANEURYSM WAS LARGE.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS PATIENT DIED AT HOME ONE WEEK AFTER TREATMENT OF A BASILAR ARTERY ANEURYSM WITH A PIPELINE FLEX DEVICE. THE PHYSICIAN REPORTED THE CAUSE OF DEATH IS UNKNOWN, COULD BE CARDIAC OR THROMBOTIC. IT WAS REPORTED THAT NO AUTOPSY WILL BE PERFORMED. THE PATIENT WAS TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM IN BASILAR ARTERY. THE PATIENT'S ANATOMY WAS VERY TORTUOUS. THE PIPELINE FLEX WAS IMPLANTED SUCCESSFULLY AND WAS FULLY APPOSED TO THE BASILAR ARTERY. ONE DAY POST PROCEDURE, THE PATIENT HAD A CTA FOR HEADACHE WHICH SHOWED THAT THE ANEURYSM HAD ALREADY THROMBOSED AND WAS DISCHARGED HOME. THE PATIENT RECEIVED DUAL ANTI-PLATELET THERAPY, WITH UNKNOWN PRU LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610422 PIPELINE EMBOL. DEVICE 5.00MM X 25MM INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MEDTRONIC COVIDIEN FA-71500-25 9942291

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Death