BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE FR2

    MDR report key: 4471471 · Received January 30, 2015

    Report

    Report Number
    2029214-2015-00079
    Event Type
    Injury
    Date Received
    January 30, 2015
    Date of Event
    September 8, 2014
    Report Date
    January 26, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    NRY
    PMA / PMN Number
    K123378
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED. THE LOT HISTORY RECORD OF THE REPORTED LOT NUMBER SHOWED, NO DISCREPANCIES THAT MIGHT HAVE CONTRIBUTED TO THE REPORTED ISSUE. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE (B)(4). THE PATIENT WAS RANDOMIZED TO IV TPA + SOLITAIRE FR AND TREATED ON (B)(6) 2014. IT WAS REPORTED THAT TWO SOLITAIRE DEVICES WERE USED TO ATTEMPT TO REMOVE THE CLOT. HOWEVER BOTH DEVICES COULD NOT RETRIEVE THE CLOT. THE VASOSPASM OCCURRED BEFORE AND AFTER THE USE OF THE SOLITAIRE DEVICES. HEMORRHAGIC TRANSFORMATION BY DEFINITION IS WITHIN THE INFARCT. THE CEC (CLINICAL ENDPOINT COMMITTEE) COMMENTED THAT SINCE THI SEGMENT WAS UNUSUALLY DIFFICULT TO PROBE¿ AND THIS IN MANY ATTEMPTS (THE TRANSENDEX WIRE KEPT ON JUMPING INTO THE OTHER ARTERY SEGMENT) "MILD VASOSPASMS DEVELOPED IN THE REGION AS A RESULT OF THESE WIRE MANEUVERS. FOR THIS REASON, THE OPERATION WAS TERMINATED AT THIS POINT TO AVOID FURTHER DETERIORATION IN THE FINDINGS. NO TREATMENT WAS PROVIDED FOR THE VASOSPASM AND IT WAS NOTED AS PROCEDURE RELATED. THE PATIENT ALSO HAD AN ADVERSE EVENT OF VOMITING AND HYPERGLYCEMIA. ON (B)(6) 2015, THE CEC ADJUDICATED A NEW EVENT OF PARENCHYMAL HEMATOMA 1 (PH1) WITH RELATIONSHIP OF PROCEDURE/TREATMENT THAT RESOLVED ON (B)(6) 2014 (90 DAY). ON (B)(6) 2015, THERE WERE NO SIGNS AND SYMPTOMS OF THE PARENCHYMAL HEMATOMA, AND NO SPECIFIC TREATMENT WAS GIVEN, IT WAS A RADIOGRAPH ADVERSE EVENT. ON (B)(6) 2015, IT WAS REPORTED THAT THE CORE LAB READING, 27 HR CT (COMPUTED TOMOGRAPHY) OR MR (MAGNETIC RESONANCE) REPORT FROM THE ADJUDICATION PACKET WILL CONFIRM THE PRESENCE OF PARENCHYMAL HEMORRHAGE. THE PATIENT IMPROVED NIHSS SCORE BETWEEN SCREENING AND 27 HR BUT DETERIORATED (BECAME SYMPTOMATIC) BETWEEN 27 HR (9 SEPT) AND 7 DAY ((B)(6)) DUE TO MALIGNANT CEREBRAL EDEMA, BUT LATER IMPROVED AT 30 DAYS AND RECOVERED AT 90 DAYS FROM THE BASELINE CONDITION IN TERMS OF NEUROLOGICAL DEFICIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70907 SOLITAIRE FR2 CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE) SFR2-4-15 9801499

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Disability