BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERCI RETRIEVER V 2.5 FIRM

    MDR report key: 1709853 · Received June 1, 2010

    Report

    Report Number
    2954917-2010-00009
    Event Type
    Injury
    Date Received
    June 1, 2010
    Date of Event
    May 7, 2010
    Report Date
    June 1, 2010
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K081305
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO EVIDENCE OF CONCENTRIC MEDICAL DEVICE MALFUNCTION AND THE DEVICE INSTRUCTIONS FOR USE LIST RELATED POSSIBLE COMPLICATIONS. ALSO, WHILE THE USE OF THE CONCENTRIC MEDICAL DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT OUTCOME, THERE ARE OTHER FACTORS INDEPENDENT OF THE SUBJECT DEVICES (E.G., PATIENT FACTORS, DEVICE USE FACTORS, OTHER DEVICES EMPLOYED, DRUGS ADMINISTERED, ETC.) THAT ALSO MAY HAVE CAUSE OR CONTRIBUTED TO THE OUTCOME.

    Description of Event or Problem · 1

    PT WAS (B)(6) FEMALE FIRST SEEN ABOUT 2.5 HOURS AFTER STROKE SYMPTOM ONSET (NIHSS 10). SHE INITIALLY RECEIVE IV-TPA. ANGIOGRAPHY INDICATED TOTAL OCCLUSION OF THE RIGHT MIDDLE CEREBRAL ARTERY (R-MCA) M1 BRANCH. AFTER THE FIRST PASS, CLOT WAS REMOVED AND TIMI-2 FLOW WAS OBTAINED IN THE DISTAL MCA TERRITORY. A FOLLOW-UP ANGIOGRAM AFTER A SECOND PASS REVEALED A POSSIBLE PERFORATION IN THE CAVERNOUS ICA, NO FLOW TO THE MCA, AND THE FORMATION OF A CAROTID-CAVERNOUS FISTULA (CCF) WHERE THE POSSIBLE PERFORATION OCCURRED. THE FOLLOWING DEVICES HAD PASSED THROUGH CAVERNOUS CAROTID ARTERY: BOSTON SCIENTIFIC TRANSEND EX SOFT TIP GUIDEWIRE, MICROCATHETER 18L, DISTAL ACCESS CATHETER 4.3F, AND RETRIEVER V 2.5 FIRM. WHILE CONSIDERING CCF TREATMENT OPTIONS, THE PHYSICIAN MADE A FEW MORE ANGIOGRAPHY RUNS. THERE WAS EXCELLENT CROSS FILLING TO THE R-MCA TERRITORY VIA THE LEFT SIDE CIRCULATION. ADDITIONALLY, AFTER SEVERAL MINUTES THERE WAS NOW RESTORED FLOW THROUGH THE R-ICA TO THE DISTAL TERRITORY. THE FLOW THROUGH THE CCF SEEMED SIGNIFICANTLY DIMINISHED BUT STILL PRESENT. THE DECISION WAS MADE TO CLOSELY MONITOR THE PATIENT. THE FOLLOWING DAY, THE PATIENT WAS ALERT AND HAD RESTORED MOVEMENT TO HER EXTREMITIES. THERE WERE SOME COMPLICATIONS TO THE RIGHT EYE AND THE DECISION WAS MADE TO PERFORM A COIL EMBOLIZATION PROCEDURE TO TREAT THE CCF. IT WAS NOT CLEAR IF THE CCF WAS CAUSED BY PERFORATION DUE TO THE USE OF THE GUIDEWIRE, MICROCATHETER, DAC OR RETRIEVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVER V 2.5 FIRM CATHETER, PERCUTANEOUS NRY CONCENTRIC MEDICAL, INC. 90112 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention