BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERCI RETRIEVER V 2.0 SOFT

    MDR report key: 2492649 · Received March 13, 2012

    Report

    Report Number
    2954917-2012-00017
    Event Type
    Death
    Date Received
    March 13, 2012
    Date of Event
    August 28, 2011
    Report Date
    March 13, 2011
    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., 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 2.0 SOFT DEVICE COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    PT WAS A (B)(6) FEMALE WITH BASILAR ARTERY AND RIGHT P1 OCCLUSION. ONE PASS WITH MERCI RETRIEVER V 2.0 SOFT AND TWO PASSES WITH V 2.0 FIRM RETRIEVER WERE MADE, RESULTING IN A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 0. DURING PROCEDURE, 27 MG OF TISSUE PLASMINOGEN ACTIVATOR (T-PA) WAS ADMINISTERED TO THE PT. ALSO DURING PROCEDURE, A HEMORRHAGE AT THE BASILAR ARTERY WAS NOTICED. A PERIOPERATIVE INTUBATION WAS PERFORMED AND EMBOLIZATION COIL WAS USED TO BLOCK THE BASILAR ARTERY. THE PT EXPIRED THE FOLLOWING DAY. PHYSICIAN BELIEVES THAT THE MERCI RETRIEVERS CAUSED THE HEMORRHAGE. PHYSICIAN ALSO STATED THAT IT IS UNK WHETHER THE HEMORRHAGE ATTRIBUTED TO THE PT'S OUTCOME OR NOT SINCE THE PT HAD A NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) SCORE OF 38.

    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| O| R