BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE FR

    MDR report key: 6847369 · Received September 6, 2017

    Report

    Report Number
    2029214-2017-01019
    Event Type
    Injury
    Date Received
    September 6, 2017
    Date of Event
    February 23, 2013
    Report Date
    September 6, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    NRY
    PMA / PMN Number
    K113455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LEE, J. S., HONG, J. M., LEE, S., JOO, I. S., LIM, Y. C., <(>&<)> KIM, S. Y. (2013). THE COMBINED USE OF MECHANICAL THROMBECTOMY DEVICES IS FEASIBLE FOR TREATING ACUTE CAROTID TERMINUS OCCLUSION. ACTA NEUROCHIRURGICA, 155(4), 635-641. DOI:10.1007/S00701-013-1649-5 THE SOLITAIRE DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION; PRODUCT ANALYSIS CANNOT BE PERFORMED. BASED ON THE REPORTED 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. MDRS RELATED TO THIS ARTICLE: 2029214-2017-01017 AND 2029214-2017-01018. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC LITERATURE REVIEW FOUND REPORTS OF HEMORRHAGE AND INFARCTION AFTER SOLITAIRE MECHANICAL THROMBECTOMY. THE PURPOSE OF THIS ARTICLE WAS TO INVESTIGATE THE FEASIBILITY OF COMBINED STENT-ASSISTED AND CLOT ASPIRATION MECHANICAL THROMBECTOMY FOR EFFECTIVE RECANALIZATION OF ACUTE CAROTID TERMINUS OCCLUSION. THE AUTHORS REVIEWED TEN PATIENTS (MEDIAN AGE 69 YEARS; SIX FEMALE; FOUR MALE) WITH ACUTE ISCHEMIC STROKE SECONDARY TO CAROTID TERMINUS OCCLUSION. THE PATIENTS UNDERWENT INTRA-ARTERIAL TREATMENT WITH BOTH STENT RETRIEVAL (SOLITAIRE AB/FR) AND NEGATIVE-PRESSURED CLOT ASPIRATION SYSTEMS. THE ARTICLE STATES THAT THE FOLLOWING OUTCOMES WERE OBSERVED FOLLOWING THE PROCEDURE: - ONE PATIENT EXPERIENCED HEMORRHAGIC TRANSFORMATION TYPE 2 - THREE PATIENTS EXPERIENCED PARENCHYMAL HEMATOMA TYPE 1 - ONE PATIENT EXPERIENCED MALIGNANT INFARCTION AND UNDERWENT CRANIECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625164 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other