BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERCI RETRIEVER V 2.5 SOFT

    MDR report key: 2724194 · Received August 29, 2012

    Report

    Report Number
    2954917-2012-00104
    Event Type
    Death
    Date Received
    August 29, 2012
    Date of Event
    March 9, 2012
    Report Date
    August 29, 2012
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K081305
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO EVIDENCE OF CONCENTRIC MEDICAL DEVICE MALFUNCTION AND THE DEVICE INSTRUCTIONS FOR USE LISTS RELATED POSSIBLE COMPLICATIONS. ALSO, WHILE THE CONCENTRIC MEDICAL DEVICE USE MAY HAVE CAUSED OR CONTRIBUTED TO THE PT OUTCOME, THERE ARE OTHER FACTORS INDEPENDENT OF THE SUBJECT DEVICE (E.G. PT FACTORS, DEVICE USE FACTORS, OTHER DEVICES EMPLOYED, DRUGS ADMINISTERED, ETC.) THAT ALSO MAY HAVE CAUSED OR CONTRIBUTED TO THE OUTCOME. BECAUSE THE DEVICE WAS NOT RETURNED TO CONCENTRIC MEDICAL, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. ALSO, BECAUSE THE LOT NUMBER FOR THE DEVICE WAS NOT REPORTED TO CONCENTRIC MEDICAL, THE MFG RECORDS FOR THE MERCI RETRIEVER V 2.5 SOFT DEVICE COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    PT WAS AN (B)(6) FEMALE WITH BASILAR ARTERY OCCLUSION. PHYSICIAN MADE THREE PASSES WITH A MERCI RETRIEVER V 2.5 SOFT FOR THE OCCLUSION. PT HAD A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 2B AFTER TREATMENT. SUBARACHNOID HEMORRHAGE (SAH) WAS CONFIRMED POST-OPERATION. TISSUE PLASMINOGEN ACTIVATOR (T-PA) WAS NOT ADMINISTERED TO THE PT DURING PROCEDURE. MEDICAL INTERVENTION WAS NOT PERFORMED. PT EXPIRED ON (B)(6) 2012 DUE TO DEVELOPMENT OF CEREBRAL INFARCTION. PHYSICIAN BELIEVES THAT IT IS POSSIBLE THAT THE SAH IS RELATED TO THE USE OF THE MERCI RETRIEVER AND THAT THE PT'S OUTCOME IS DUE TO DEVELOPMENT OF CEREBRAL INFARCTION AND NOT RELATED TO THE SAH. PHYSICIAN ALSO BELIEVES THAT IT CANNOT BE SPECIFIED WHETHER THE SAH WAS AN ACTUAL HEMORRHAGE OR EXTRAVASATION OF CONTRAST MEDIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVER V 2.5 SOFT CATHETER, PERCUTANEOUS NRY CONCENTRIC MEDICAL, INC. 90111 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death| O