BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE FR

    MDR report key: 7517050 · Received May 15, 2018

    Report

    Report Number
    2029214-2018-00415
    Event Type
    Injury
    Date Received
    May 15, 2018
    Date of Event
    September 24, 2012
    Report Date
    May 15, 2018
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    PMA / PMN Number
    K113455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DAVALOS, A., PEREIRA, V. M., CHAPOT, R., BONAFE, A., ANDERSSON, T., <(>&<)> GRALLA, J. (2012). RETROSPECTIVE MULTICENTER STUDY OF SOLITAIRE FR FOR REVASCULARIZATION IN THE TREATMENT OF ACUTE ISCHEMIC STROKE. STROKE, 43(10), 2699-2705. DOI:10.1161/STROKEAHA.112.663328 THE SOLITAIRE FR DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION; PRODUCT ANALYSIS CANNOT BE PERFORMED. BASED ON THE PROVIDED INFORMATION, THERE DOES NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICES DURING USE. THE EVENTS OCCURRED IN THE PATIENTS POST-PROCEDURE AND THE CAUSES COULD NOT BE CONCLUSIVELY DETERMINED FROM THE PROVIDED INFORMATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT OF PATIENT COMPLICATIONS DURING OR AFTER SOLITAIRE FR THROMBECTOMY. THE PURPOSE OF THIS ARTICLE WAS TO EVALUATE THE SAFETY AND EFFICACY OF SOLITAIRE FR IN TREATMENT OF ACUTE ISCHEMIC STROKE SECONDARY TO LARGE ARTERY OCCLUSION. THE AUTHORS EVALUATED 141 PATIENTS WITH ACUTE ISCHEMIC STROKE WHO UNDERWENT SOLITAIRE FR THROMBECTOMY AS A FIRST-CHOICE DEVICE. OF THE 141 PATIENTS, 62 WERE FEMALE; MEAN AGE WAS 66.3 YEARS. - 45 PATIENTS WERE FOUND TO HAVE HEMORRHAGIC TRANSFORMATION AT 24 HOURS - 5 PATIENTS EXPERIENCED SYMPTOMATIC INTRACRANIAL HEMORRHAGE, WHICH WAS DEFINED AS PARENCHYMAL HEMATOME TYPE 2 WITH NIHSS INCREASE > 4 POINTS. - 12 PATIENTS EXPERIENCED SUBARACHNOID HEMORRHAGE. IN ONE PATIENT, SUBARACHNOID HEMORRHAGE WAS RELATED TO A TECHNICAL ISSUE (DEVICE MANIPULATION IN A SMALL VESSEL). - 2 PATIENTS EXPERIENCED VESSEL DISSECTION OCCURRED. IN ONE PATIENT, DISSECTION REQUIRED PLACEMENT OF A STENT. - 9 PATIENTS EXPERIENCED DISTAL EMBOLI NOT PRESENT AT ONSET. TWO OF THE 9 PATIENTS HAD NEW ISCHEMIA WITH CLINICAL IMPACT: THE FIRST HAD A NEW INFARCT ON THE ANTERIOR CEREBRAL ARTERY TERRITORY WITH INITIAL TARGET VESSEL BEING M1 TO M2 AND THE SECOND A NEW INFARCT ON THE POSTERIOR INTERNAL CAROTID ARTERY WITH THE INITIAL TARGET VESSEL BEING THE BASILAR ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359356 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R