BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4991443 · Received August 11, 2015

    Report

    Report Number
    2029214-2015-00862
    Event Type
    Death
    Date Received
    August 11, 2015
    Date of Event
    May 17, 2014
    Report Date
    July 16, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    PMA / PMN Number
    P100018.S004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE WEBSITE: HTTP://LINK.SPRINGER.COM/ARTICLE/10.1007%2FS00062-014-0310-X. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS NOT REPORTED. THERE IS NO ALLEGATION OR EVIDENCE OF POTENTIAL OR CONFIRMED MANUFACTURING ISSUES. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICE DURING USE. THE EVENT OCCURRED IN THE PATIENT POST PROCEDURE AND ITS CAUSE WAS UNKNOWN. THE DEVICE MALFUNCTION EVENT FROM THIS ARTICLE WAS REPORTED IN MDR# 2029214-2015-00861.

    Description of Event or Problem · 1

    MEDTRONIC (B)(4) RECEIVE INFORMATION FROM A LITERATURE THAT DURING A PIPELINE EMBOLIZATION DEVICE (PED) PROCEDURE, ONE PIPELINE FELL INTO THE ANEURYSM AND POST PROCEDURE THE PATIENT EXPERIENCE DIFFUSE SUBARACHNOID HEMORRHAGE WITH VENTRICULAR SPREAD 12 HOUR POST PIPELINE AND COILS PROCEDURE AND DIED 24 HOUR LATER. THE PATIENT WAS TREATED FOR A BROAD-BASED SACCULAR ANEURYSM OF THE POSTERIOR WALL OF THE LEFT SUPRACLINOID CAROTID ARTERY. ITS MAXIMUM DIAMETER WAS 35 MM AND THE NECK/SAC RATIO WAS 0.6. DUE TO THE ANEURYSM SIZE AND NECK AND THE CAROTID LOCALIZATION, AN ENDOVASCULAR APPROACH WITH PED WAS PLANNED. THE DISTAL TIP OF THE FIRST PED WAS PLACED INTO THE PROXIMAL M1 SEGMENT, TO IMPROVE THE STABILITY OF THE SYSTEM; USING THE "JAILING" TECHNIQUE, A SINGLE PED WAS DEPLOYED, THEN 15 COILS WERE PLACED. DUE TO THE LARGE DEFECT OF THE VESSEL WALL AT THE NECK AND LACK OF RADIAL FORCE OF THE PED, AFTER THE DEPLOYMENT, WHEN THE MICROCATHETER WAS REMOVED, THE DEVICE SHORTENED AND FELL INTO THE ANEURYSM SAC; PROBABLY THE LENGTH OF THE PED WAS UNDERESTIMATED, BECAUSE OF THE DEVICE ENLARGEMENT (MDR# 2029214-2015-00861). THE ICA WAS THEN RE-CATHETERIZED: THE DISTAL TIP OF THE SECOND PED WAS POSITIONED JUST BEFORE THE ICA BIFURCATION AND A SECOND DEVICE, LONGER THAN THE FIRST ONE, WAS DEPLOYED WITH A GOOD ANGIOGRAPHIC RESULT. THE PROCEDURE WAS WELL TOLERATED AND THE IMMEDIATE POST-PROCEDURAL COURSE WAS REGULAR, WITH NO NEUROLOGICAL SYMPTOMS. HOWEVER, 12 H LATER, DURING THE NIGHT, THE PATIENT BECAME COMATOSE AND WAS IMMEDIATELY INTUBATED. A CT SCAN SHOWED DIFFUSE SUBARACHNOID HEMORRHAGE (SAH) WITH VENTRICULAR SPREAD. NO FURTHER TREATMENT WAS DECIDED. RAPID WORSENING UP TO BRAIN DEATH OCCURRED AND THE PATIENT DIED 24 H LATER (MDR# 2029214-2015-00862). CITATION: BRIGANTI F, LEONE G, LAURIOLA W, ET AL. EARLY FATAL HEMORRHAGE AFTER ENDOVASCULAR TREATMENT OF A GIANT ANEURYSM WITH FLOW DIVERTER DEVICE AND COILS. CLIN NEURORADIOL (2015) 25:201-205.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523657 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE) FA-71350-25

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death