BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLITAIRE FR

    MDR report key: 4232966 · Received November 6, 2014

    Report

    Report Number
    2029214-2014-00630
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    September 16, 2014
    Report Date
    October 8, 2014
    Manufacturer
    IRVINE
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE SOLITAIRE FR PMS STUDY. TREATMENT OF AN ACUTE STROKE. THE PATIENT¿S CONDITION PRIOR TO THE THROMBOLYSIS COMPLICATION WAS HYPERTENSION, HYPERLIPIDEMIA, ATRIAL FIBRILLATION, BLOOD PRESSURE: 179/89, BLOOD SUGAR LEVEL: 119MG/DL, NIHSS: 17, MRS: 0, ASPECTS-CT SCORE: 10, ASPECTS-DWI SCORE: 8, OCCLUDED VESSEL: LEFT MIDDLE CEREBRAL ARTERY TICI:0, DIAMETER OF OCCLUDED VESSEL: 1.9MM, LENGTH OF OCCLUDED VESSEL: 10MM. ON (B)(6) 2014, THE PATIENT WAS ADMITTED TO THE ER (EMERGENCY ROOM) DUE TO AN INTRACRANIAL HEMORRHAGE. THE PATIENT COMPLAINED OF CHEST PAINS AND DIFFICULTY BREATHING. RIGHT PARALYSIS AND APHASIA WERE CONFIRMED AND PATIENT WAS SWITCHED TO T-PA. AN OBSERVATION SUSPECTING OCCLUSION AT THE ASCENDING BRANCH OF LEFT MCA, M2 WAS FOUND ON THE MRI IMAGE TAKEN; DWI-ASPECT: 8 AND THERE WAS A MISMATCH IN DWI-CLINICAL. THE PATIENT WAS TRANSFERRED TO THE ANGIOGRAPHY SUITE WHILE TAKING T-PA ADMINISTRATION. SINCE THE PATIENT HAD SEVERE RESTLESS CONDITIONS, THE ACUTE REVASCULARIZATION TREATMENT WAS PERFORMED WHILE TAKING PROPOFOL FOR PAIN RELIEF. OCCLUSION AT THE ASCENDING BRANCH OF LEFT MCA, M2 WAS CONFIRMED. THE PHYSICIAN TRIED TO APPROACH THE LEFT MCA M2 ASCENDING BRANCH; HOWEVER, IT WAS DIFFICULT TO DO SO. THE PHYSICIAN CONFIRMED A SMALL BLEEDING LESION ON THE LEFT TEMPORAL LOBE THROUGH PER-CT IMAGE AND THE THROMBUS WAS FOUND AT THE M2 OF MCA M2 ASCENDING BRANCH THROUGH THE M3. THE SOLITAIRE FR 4 X 20 FLOW RESTORATION DEVICE WAS INSERTED AND DEPLOYED AT THE DISTAL M2. SINCE THE THROMBUS ON THE M3 SIDE COULD NOT BE COVERED, TEMPORARY BYPASS WAS NOT CONFIRMED AND THE DEVICE WAS NOT ADVANCED FURTHER. THE PHYSICIAN ATTEMPTED TO REMOVE THE THROMBUS BY ASPIRATING THE MAX PUMP FROM 5 MAX; HOWEVER, MOST OF THE THROMBUS COULD NOT BE REMOVED. PERFORMING THE SAME METHOD, THE SOLITAIRE FR 4 X 20 WAS DELIVERED FURTHER IN THE M2. ANGIOGRAPHY SHOWED SLIGHT ANTEGRADE FLOW ON THE LEFT MCA M2 ASCENDING BRANCH WAS CONFIRMED. HOWEVER, ON THE FINAL ANGIOGRAPHIC IMAGING, THERE WAS NO EXTRACT FURTHER THAN THE ROOT OF MCA M2 ASCENDING BRANCH. TICI: 0, ON THE XPERCT IMAGING, THE BLEEDING LESION OF THE LEFT TEMPORAL LOBE WAS NOT ENLARGED. THE RIGHT 9FR LONG SHEATH WAS FIXED WITH AN ANGIO-SEAL. THE BLEEDING LESION DID NOT SEEM TO BE ENLARGED THROUGH THE REGULAR CT IMAGING AS WELL. THE SOLITAIRE WAS REMOVED FROM THE PATIENT. THE PATIENT WAS TRANSFERRED TO THE SCU (SPECIAL CARE UNIT) AND WAS RECOVERING. THE INTRACRANIAL HEMORRHAGE THAT OCCURRED DURING REVASCULARIZATION WITH THE SOLITAIRE DEVICE WAS NOT RELATED TO THE USAGE OF THE SOLITAIRE FR DEVICE SINCE THE HEMORRHAGE OCCURRED AT THE DIFFERENT LOCATION THAN WHERE THE OCCLUSION WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715202 SOLITAIRE FR FLOW RESTORATION NRY IRVINE SFR-4-20 9876067

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Disability