BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERCI RETRIEVER V 2.0 SOFT

    MDR report key: 2483426 · Received March 5, 2012

    Report

    Report Number
    2954917-2012-00003
    Event Type
    Injury
    Date Received
    March 5, 2012
    Date of Event
    September 17, 2011
    Report Date
    March 5, 2012
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    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) MALE WITH A RIGHT INTERNAL CAROTID ARTERY (ICA) OCCLUSION. PHYSICIAN MADE THREE PASSES WITH A MERCI RETRIEVER V 2.0 SOFT. AS THE PT'S VESSEL WAS STILL OCCLUDED AFTER THE THREE PASSES, PHYSICIAN ADMINISTERED UROKINASE (UK). AS A RESULT, THE RIGHT ICA WAS RECANALIZED. PT HAD A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 3 AFTER THE TREATMENT. A HEMORRHAGE DUE TO REVASCULARIZATION WAS CONFIRMED AFTER TREATMENT. TISSUE PLASMINOGEN ACTIVATOR (T-PA) WAS NOT USED DURING PROCEDURE. CEREBRAL DECOMPRESSION AND REMOVAL OF CLOT BY CRANIOTOMY WAS ALSO PERFORMED. PHYSICIAN BELIEVES THAT THE APPLICATION OF UK IN ADDITION TO THE MERCI DEVICE CAUSED THE HEMORRHAGE. PHYSICIAN ALSO STATED THAT THE PT HAD A PROTHROMBIN TIME INTL NORMALIZED RATIO (PT-INR) OF 1.4 DUE TO WARFARIN INTAKE FOR THE TREATMENT OF PAST ILLNESS (CARDIOGENIC EMBOLUS) WHICH MAY HAVE ALSO CONTRIBUTED TO THE HEMORRHAGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other| R