BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE

    MDR report key: 7447264 · Received April 20, 2018

    Report

    Report Number
    2029214-2018-00307
    Event Type
    Death
    Date Received
    April 20, 2018
    Date of Event
    December 11, 2017
    Report Date
    April 20, 2018
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED AS IT WAS IMPLANTED. ANEURYSM RUPTURE AND DEATH ARE KNOWN INHERENT RISKS OF THE ENDOVASCULAR PROCEDURE AND ARE DOCUMENTED IN OUR DEVICE¿S INSTRUCTIONS FOR USE (IFU). ALL DEVICES ARE 100% TESTED AND ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. THERE WAS NO ALLEGATION THAT THE DEVICES DID NOT FUNCTION AS DESIRED OR THAT A MALFUNCTION OCCURRED DURING THE FIRST PROCEDURE OR THE SECOND. BASED ON THE REPORTED INFORMATION, THERE WAS NO REASONABLY SUGGESTION THAT A MALFUNCTION OR QUALITY DEFICIENCY OF THE PIPELINE DEVICE OCCURRED DURING THE TREATMENT PROCEDURE OR AFTER. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE, BUT RATHER A PATIENT CONDITION AND POST PROCEDURE RELATED EVENT, AND ITS EXACT CAUSE IS UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT THROUGH LITERATURE REVIEW OF ¿TREATMENT OF BLOOD BLISTER ANEURYSMS OF THE INTERNAL CAROTID ARTERY WITH FLOW DIVERSION¿ (MAXIM MOKIN, ANGEL CHINEA, CHRISTOPHER T PRIMIANI, ZEGUANG REN, PETER KAN, VISISH M SRINIVASAN, RICARDO HANEL, PEDRO A GUILAR-SALINAS, AQUILLA S TURK, RAYMOND D TURNER, M IMRAN CHAUDRY, ANDREW J RINGER). MEAN AGE WAS 52.8±13.9 YEARS AND 67% (29/43) WERE WOMEN. THERE WAS ONE ANEURYSM RE-RUPTURE 4 DAYS AFTER TREATMENT. TWO ADDITIONAL PED WERE PLACED. HOWEVER, THE PATIENT PASSED AWAY ON DAY 7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290521 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Death