BEUDAMED
    FDA Adverse Event Death Summary report: N

    V 2.0 FIRM EXT PEBAX

    MDR report key: 2915821 · Received January 15, 2013

    Report

    Report Number
    0002954917-2013-00006
    Event Type
    Death
    Date Received
    January 15, 2013
    Date of Event
    December 28, 2011
    Report Date
    December 26, 2012
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    PMA / PMN Number
    K090085
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: FOR ANTICIPATED PROCEDURAL AND PATIENT COMPLICATION. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. 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. HEMORRHAGE AND DEATH ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL AND PATIENT COMPLICATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN SUCCESSFULLY PERFORMED TWO PASSES WITH RETRIEVAL DEVICES TO TREAT A LEFT MIDDLE CEREBRAL ARTERY (L-MCA) M1 OCCLUSION. THE PATIENT HAD A THROMBOLYSIS IN CEREBRAL ISCHEMIA (TICI) SCORE OF 2A AFTER TREATMENT. POST PROCEDURE THE PATIENT WAS STABLE; HOWEVER, LATER THE SAME DAY THE PATIENT'S LEVEL OF CONSCIOUSNESS (LOC) DECREASED AND CT SCAN REVEALED A SUBARACHNOID HEMORRHAGE (SAH). THE PATIENT WAS GIVEN "PRESERVATIVE MANAGEMENT IN COMPLYING WITH WISHES OF THE PATIENT'S FAMILY". THE PATIENT'S LOC CONTINUED TO DECREASE GRADUALLY AND NINE DAYS POST PROCEDURE, THE PATIENT DIED. THE PHYSICIAN STATED THAT THE HEMORRHAGE WAS THE CAUSE OF THE PATIENT OUTCOME AND THE CAUSE OF THE SAH MAY BE RELATED TO VESSEL DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN SUCCESSFULLY PERFORMED TWO PASSES WITH RETRIEVAL DEVICES TO TREAT A LEFT MIDDLE CEREBRAL ARTERY (L-MCA) M1 OCCLUSION. THE PATIENT HAD A THROMBOLYSIS IN CEREBRAL ISCHEMIA (TICI) SCORE OF 2A AFTER TREATMENT. POST PROCEDURE THE PATIENT WAS STABLE; HOWEVER, LATER THE SAME DAY THE PATIENT'S LEVEL OF CONSCIOUSNESS (LOC) DECREASED AND CT SCAN REVEALED A SUBARACHNOID HEMORRHAGE (SAH). THE PATIENT WAS GIVEN "PRESERVATIVE MANAGEMENT IN COMPLYING WITH WISHES OF THE PATIENT'S FAMILY." THE PATIENT'S LOC CONTINUED TO DECREASE GRADUALLY AND NINE DAYS POST PROCEDURE, THE PATIENT DIED. THE PHYSICIAN STATED THAT THE HEMORRHAGE WAS THE CAUSE OF THE PATIENT OUTCOME AND THE CAUSE OF THE SAH MAY BE RELATED TO VESSEL DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23332 V 2.0 FIRM EXT PEBAX CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death MERCI RETRIEVER (CONCENTRIC)