BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE? REVASCULARIZATION DEVICE

    MDR report key: 4528937 · Received February 19, 2015

    Report

    Report Number
    2029214-2015-00178
    Event Type
    Injury
    Date Received
    February 19, 2015
    Report Date
    January 23, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT WAS CREATED TO CAPTURE THE EVENT OF THROMBUS RECEIVED FROM THE ARTICLE: MA ET AL. MECHANICAL THROMBECTOMY WITH SOLITAIRE STENT FOR ACUTE INTERNAL CAROTID ARTERY OCCLUSION WITHOUT ATHEROSCLEROTIC STENOSIS: DISSECTION OR CARDIOGENIC THROMBOEMBOLISM. EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES, 2014; 18:1324-1332. IT SHOULD BE NOTED THAT THE THROMBUS WAS CAUSED BY A PRE-EXISTING FLAP FROM A DISSECTION NOT CAUSED BY THE SOLITAIRE. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT REPORTED. THE IFU (INSTRUCTIONS FOR USE) INCLUDES A WARNING "DO NOT PERFORM MORE THAN THREE RECOVERY ATTEMPTS IN THE SAME VESSEL USING THE SOLITAIRE FR REVASCULARIZATION DEVICE." (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE ARTICLE: MA ET AL. MECHANICAL THROMBECTOMY WITH SOLITAIRE STENT FOR ACUTE INTERNAL CAROTID ARTERY OCCLUSION WITHOUT ATHEROSCLEROTIC STENOSIS: DISSECTION OR CARDIOGENIC THROMBOEMBOLISM. EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES, 2014; 18:1324-1332. MEDTRONIC (COVIDIEN) RECEIVED INFORMATION REGARDING A MANUFACTURED PRODUCT AND ADVERSE EVENTS AROUND IT. (SEVEN) PATIENTS (MEAN AGE 56, 4 MALES) WERE TREATED WITH SOLITAIRE. THE DATA WAS RETROSPECTIVELY REVIEWED. A PATIENT INITIALLY PRESENTED WITH ACUTE ICA (INTERNAL CAROTID ARTERY) OCCLUSION DUE TO CAROTID DISSECTION AND WAS FURTHER BELIEVED TO BE DISSECTION SUBTYPE: INTIMAL FLAP WITH SUBINTIMAL AND INTRALUMINAL THROMBUS. AFTER THE FIRST PASS WITH THE SOLITAIRE, LITTLE THROMBUS IN THE DISTAL DISSECTION WAS REMOVED. (TWO) MORE PASSES WERE DONE AND NOTHING WAS RETRIEVED. ON THE FOURTH PASS, IMMEDIATE CROSS-FILLING OF THE RIGHT ANTERIOR CIRCULATION WAS ENCOUNTERED WHEN THE SOLITAIRE STENT WAS LOCATED IN THE SUPRACLINOID SEGMENT. THE FLOATING INTIMAL FLAP REMAINED AND RESULTED IN REPEAT OCCLUSION OF THE ARTERY OR FORMED A SECONDARY THROMBUS. THIS WAS NOT DEVICE RELATED AS THE FLAP WAS FROM THE PRE-EXISTING DISSECTION. THE ARTICLE WAS AIMED TO FIND USEFUL EVIDENCE TO JUDGE THE CONDITION OF PATIENTS WITH ACCURACY AND ESTABLISH REASONABLE TREATMENT PROTOCOLS. IT CONCLUDES THAT MECHANICAL THROMBECTOMY IN ACUTE STROKE DUE TO ICA/MCA OCCLUSION IS FEASIBLE AND SAFE, WITH HIGH RATES OF RECANALIZATION AND FAVORABLE FUNCTIONAL OUTCOMES. INFORMATION RECEIVED FROM THE SAME ARTICLE AS MDR# 2029214-2015-00177.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119875 SOLITAIRE? REVASCULARIZATION DEVICE CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE) NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other