BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD

    MDR report key: 6713331 · Received July 14, 2017

    Report

    Report Number
    2183870-2017-00304
    Event Type
    Injury
    Date Received
    July 14, 2017
    Date of Event
    October 29, 2016
    Report Date
    June 16, 2017
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    K051379
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: AVERAGE AGE. SEX: MAJORITY GENDER. EVENT DATE IS LITERATURE ARTICLE PUBLISHED DATE. ENDOVASCULAR TREATMENT OF ACUTE INTERNAL CAROTID ARTERY DISSECTIONS: TECHNICAL CONSIDERATIONS, CLINICAL AND ANGIOGRAPHIC OUTCOME NEURORADIOLOGY (2016) 58:1167¿1179 10.1007/S00234-016-1757-Z.

    Description of Event or Problem · 1

    STENT IMPLANTATION WAS PERFORMED IN 76 CASES. PROTÉGÉ RX SELF-EXPANDING STENTS AND RESOLUTE INTEGRITY BALLOON EXPANDABLE STENTS WERE AMONG THE DEVICES USED. IT WAS REPORTED THAT THROMBUS FORMATION OCCURRED IN 13 PATIENTS WHO WAS TREATED WITH ATRIAL INFUSION AND FURTHER STENTING AND THROMBECTOMY. NEW EMBOLI TO INTRACRANIAL VESSELS OCCURRED IN 15 PATIENTS. THROMBUS WITHIN AN IMPLANTED STENT CAUSED VESSEL OCCLUSION IN ONE CASE. INTRAPROCEDURAL HAEMORRHAGES WERE OBSERVED IN TWO PATIENTS. THREE PATIENTS SUFFERED INTRACRANIAL DISSECTION AS A RESULT OF THROMBECTOMY. POST-PROCEDURE, SIX PATIENTS SHOWED PARENCHYMAL HAEMATOMAS AND ELEVEN PATIENTS HAD A FOCAL SAH. RE-OCCLUSION OF THE ICA WAS OBSERVED ON TWO PATIENTS. AT HOSPITAL DISCHARGE, FIVE PATIENTS HAD DIED. OVERALL, SEVEN PATIENTS DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496425 PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention