BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAC 057 125CM

    MDR report key: 6046330 · Received October 21, 2016

    Report

    Report Number
    0002954917-2016-00154
    Event Type
    Death
    Date Received
    October 21, 2016
    Date of Event
    September 10, 2016
    Report Date
    December 21, 2016
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    DQY
    PMA / PMN Number
    K133177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, FUNCTIONAL TESTING AS WELL AS PHYSICAL ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION PROVIDED THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. HOWEVER, VESSEL DISSECTION, VESSEL PERFORATION, HEMORRHAGE, NEUROLOGICAL DEFICITS, COMPLICATIONS AND DEATH ARE KNOWN RISKS ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND ARE LISTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE (DFU). THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS WAS ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PROCEDURE TO TREAT AN UNRUPTURED ANEURYSM, THE SUBJECT DEVICE WITH ANOTHER MANUFACTURER GUIDEWIRE INSIDE MOVED UP DISTALLY TO THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) AND DISSECTED OR PERFORATED THE M2 MCA. THE IMPLANT WAS UNEVENTFULLY IMPLANTED ACROSS THE ANEURYSM NECK WITH PERFECT DEVICE PLACEMENT WITH VERY GOOD WALL APPOSITION AND GOOD STASIS WAS SEEN IN THE ANEURYSM IMMEDIATELY POST PROCEDURE. THE PATIENT WAS EXTUBATED IMMEDIATELY POST PROCEDURE AND WAS PERFECTLY FINE. HOWEVER, SIX (6) HOURS POST PROCEDURE IMAGING SHOWED THAT THE ANEURYSM WAS NOT RUPTURED BUT BLOOD WAS SEEN AT THE SYLVIAN FISSURE, WHICH WAS FAR FROM THE ANEURYSM AND THE IMPLANT DEVICE. THE PATIENT HAD PARENCHYMAL BLEED AND A SUBARACHNOID HEMORRHAGE (SAH) AND DEVELOPED 3RD NERVE PALSY. DECOMPRESSIVE CRANIOTOMY WAS PERFORMED TO EVACUATE OF ACCUMULATED BLOOD AND TO REDUCE INCREASED INTRACRANIAL PRESSURE. HOWEVER, THE BLEEDING WAS NOT STOPPED AND THE NEXT DAY THE PATIENT DIED DUE TO PARENCHYMAL BLEED AND SAH WITH BLOOD IN THE SYLVIAN FISSURE LEADING TO CARDIO RESPIRATORY FAILURE. THE PHYSICIAN STATED THAT THE CAUSE OF THE REPORTED ADVERSE EVENT WAS M2 MCA DISSECTION OR PERFORATION WITH THE SUBJECT DEVICE OR ANOTHER MANUFACTURER GUIDEWIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PROCEDURE TO TREAT AN UNRUPTURED ANEURYSM, THE SUBJECT DEVICE WITH ANOTHER MANUFACTURER GUIDEWIRE INSIDE MOVED UP DISTALLY TO THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) AND DISSECTED OR PERFORATED THE M2 MCA. THE IMPLANT WAS UNEVENTFULLY IMPLANTED ACROSS THE ANEURYSM NECK WITH PERFECT DEVICE PLACEMENT WITH VERY GOOD WALL APPOSITION AND GOOD STASIS WAS SEEN IN THE ANEURYSM IMMEDIATELY POST PROCEDURE. THE PATIENT WAS EXTUBATED IMMEDIATELY POST PROCEDURE AND WAS PERFECTLY FINE. HOWEVER, SIX (6) HOURS POST PROCEDURE IMAGING SHOWED THAT THE ANEURYSM WAS NOT RUPTURED BUT BLOOD WAS SEEN AT THE SYLVIAN FISSURE, WHICH WAS FAR FROM THE ANEURYSM AND THE IMPLANT DEVICE. THE PATIENT HAD PARENCHYMAL BLEED AND A SUBARACHNOID HEMORRHAGE (SAH) AND DEVELOPED 3RD NERVE PALSY. DECOMPRESSIVE CRANIOTOMY WAS PERFORMED TO EVACUATE OF ACCUMULATED BLOOD AND TO REDUCE INCREASED INTRACRANIAL PRESSURE. HOWEVER, THE BLEEDING WAS NOT STOPPED AND THE NEXT DAY THE PATIENT DIED DUE TO PARENCHYMAL BLEED AND SAH WITH BLOOD IN THE SYLVIAN FISSURE LEADING TO CARDIO RESPIRATORY FAILURE. THE PHYSICIAN STATED THAT THE CAUSE OF THE REPORTED ADVERSE EVENT WAS M2 MCA DISSECTION OR PERFORATION WITH THE SUBJECT DEVICE OR ANOTHER MANUFACTURER GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698861 DAC 057 125CM PERCUTANEOUS CATHETER DQY CONCENTRIC MEDICAL 39877

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O| R TRAXCESS 0.014 GUIDEWIRE (MICROVENTION)