BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERCI RETRIEVER V 2.0 SOFT

    MDR report key: 2519711 · Received April 2, 2012

    Report

    Report Number
    2954917-2012-00030
    Event Type
    Death
    Date Received
    April 2, 2012
    Date of Event
    December 6, 2011
    Report Date
    April 2, 2012
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K082034
    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., PATIENT 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 2.0 SOFT DEVICE COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    PT WAS A (B)(6) MALE WITH A RIGHT MIDDLE CEREBRAL ARTERY (MCA) OCCLUSION. PHYSICIAN MADE TWO PASSES WITH A MERCI RETRIEVER V 2.0 SOFT AND TWO PASSES WITH MERCI RETRIEVER V 2.0 FIRM. PT HAD A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 2A AFTER TREATMENT. A SUBARACHNOID HEMORRHAGE WAS NOTICED AT M1 REGION OF RIGHT MCA AND RIGHT FRONTAL LOBE (HEMORRHAGIC INFARCTION) AFTER PROCEDURE, CEREBRAL DECOMPRESSION WAS PERFORMED ON (B)(6) 2011 AS A MEDICAL INTERVENTION. THE PT WAS IN DEEP COMA WITH PAPILLARY ENLARGEMENT AND WORSENING OF RESPIRATORY STATUS IN THE MORNING OF (B)(6) 2011 AND EXPIRED THE SAME DAY. FORTY SIX MG OF TISSUE PLASMINOGEN ACTIVATOR (T-PA) WAS ADMINISTERED TO THE PT DURING PROCEDURE. PHYSICIAN BELIEVES THAT THE CAUSE OF THE SUBARACHNOID HEMORRHAGE IS CONSIDERED TO BE DUE TO THE USE OF MERCI RETRIEVERS. PHYSICIAN BELIEVES THAT THE HEMORRHAGIC INFARCTION AT RIGHT FRONTAL LOBE WAS PROBABLY DUE TO RECANALIZATION OF THE VESSEL. PHYSICIAN ALSO BELIEVES THAT THE CAUSE OF THE PT¿S OUTCOME WERE ISCHEMIC STROKE ITSELF, SUBARACHNOID HEMORRHAGE OR HEMORRHAGIC INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVER V 2.0 SOFT CATHETER, PERCUTANEOUS NRY CONCENTRIC MEDICAL, INC. 90109 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| R