BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE FR2

    MDR report key: 6906342 · Received September 29, 2017

    Report

    Report Number
    2029214-2017-01088
    Event Type
    Injury
    Date Received
    September 29, 2017
    Date of Event
    September 1, 2017
    Report Date
    October 17, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    NRY
    PMA / PMN Number
    K141491
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIBOLD, F., MORDASINI, P., MOSIMANN, P., PIECHOWIAK, E., DOBROCKY, T., FISCHER, U., . . . GRALLA, J. (2017). SAFETY OF THE SOLITAIRE 4 × 40 MM STENT RETRIEVER IN THE TREATMENT OF ISCHEMIC STROKE. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY. DOI:10.1007/S00270-017-1785-Z THE SOLITAIRE FR 2 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 CAUSES OF THE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED FROM THE PROVIDED INFORMATION. MDRS RELATED TO THIS ARTICLE: 2029214-2017-01088 2029214-2017-01089

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION - ADDITIONAL INFORMATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT OF INFARCT AND VASOSPASM DURING OR AFTER SOLITAIRE 2 FR MECHANICAL THROMBECTOMY. THE PURPOSE OF THIS ARTICLE WAS TO EVALUATE THE SAFETY AND EFFICACY OF THE SOLITAIRE 2 FR 4X40 FOR LARGE VESSEL OCCLUSION IN STROKE PATIENTS. THE AUTHORS RETROSPECTIVELY REVIEWED 23 PATIENTS WITH OCCLUSIONS IN THE ANTERIOR OR POSTERIOR CEREBRAL CIRCULATION. THE ARTICLE DID NOT PROVIDE PATIENT DEMOGRAPHIC INFORMATION. THE ARTICLE STATES THAT TICI 2B OR BETTER RECANALIZATION WAS ACHIEVED IN 22 PATIENTS. IN ONE PATIENT (PATIENT 19), THE INTERVENTION WAS TERMINATED AFTER ONE UNSUCCESSFUL THROMBECTOMY DUE TO AN ALREADY VISIBLE LARGE INFARCT VOLUME. IN ADDITION, THE PATIENT¿S FOLLOW-UP IMAGING SHOWED CONTRAST EXTRAVASATION. THE ARTICLE STATES THAT ONE PATIENT (PATIENT 6) EXPERIENCED INTRAPROCEDURAL VASOSPASM. THE PATIENT PRESENTED WITH AN M1 OCCLUSION AN D UNDERWENT ONE PASS OF THE SOLITAIRE DEVICE RESULTING IN TICI 3 REPERFUSION. SIGNIFICANT VASOSPASM AFTER THROMBECTOMY WAS OBSERVED IN THE PROXIMAL M1 SEGMENT. THE VASOSPASM WAS FULLY REVERSED WITH LOCAL INTRA-ARTERIAL INFUSION OF 2MG NIMODIPINE.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION FROM THE CORRESPONDING AUTHOR: OF THE 23 PATIENTS EVALUATED FOR THIS ARTICLE, 10 WERE FEMALE AND 13 WERE MALE. THE MEAN AGE WAS 38.12 YEARS. THE PATIENTS' WEIGHTS ARE NOT AVAILABLE. IN ADDITION, THE AUTHOR REPORTED THAT NONE OF THE ADVERSE EVENTS WERE DIRECTLY RELATED TO ANY MEDTRONIC DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683372 SOLITAIRE FR2 CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE) SFR2-4-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R