BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE? REVASCULARIZATION DEVICE

    MDR report key: 4528845 · Received February 19, 2015

    Report

    Report Number
    2029214-2015-00177
    Event Type
    Death
    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 DEATH 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. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS NOT REPORTED. THE DEVICE INVOLVED IN THE EVENT MOST LIKELY WILL NOT BE RETURNED FOR EVALUATION AS THIS WAS A RETROSPECTIVE REVIEW. (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 PRESENTED WITH AN ACUTE ICA (INTERNAL CAROTID ARTERY) OCCLUSION WHICH THE AUTHOR ATTRIBUTED TO CARDIOGENIC THROMBOEMBOLISM BECAUSE HE PRESENTED WITH OCCLUSION EXTENDING FROM THE TERMINUS OF THE ICA TO THE INITIAL PART OF THE MCA (MIDDLE CEREBRAL ARTERY). THREE DAYS POST PROCEDURE, THE PATIENT EXPIRED AND IT WAS ATTRIBUTED TO AGGRAVATION OF DIFFUSE BRAIN SWELLING WITHOUT IPH (INTRAPARENCHYMAL HEMORRHAGE) AND WHOSE RELATIVES REFUSED DECOMPRESSIVE CRANIECTOMY. 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# 2029214-2015-00178.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119753 SOLITAIRE? REVASCULARIZATION DEVICE CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death