BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD

    MDR report key: 12189117 · Received July 19, 2021

    Report

    Report Number
    2183870-2021-00245
    Event Type
    Injury
    Date Received
    July 19, 2021
    Date of Event
    September 18, 2020
    Report Date
    July 19, 2021
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    K072301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPACT OF ENDOVASCULAR TREATMENT ON CLINICAL OUTCOMES OF STABLE SYMPTOMATIC PATIENTS WITH SPONTANEOUS SUPERIOR MESENTERIC ARTERY DISSECTION JOURNAL OF VASCULAR SURGERY (2020) 73(4);1269-1276 DOI: 10.1016/J.JVS.2020.08.117. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    JOURNAL ARTICLE PRESENTED THE ENDOVASCULAR STENTING FOR THE TREATMENT OF SUPERIOR MESENTERIC ARTERY DISEASE (SMAD) IN THE PREVENTION OF ARTERY RUPTURE OR ANEURYSM. THE ARTICLE RETROSPECTIVELY REVIEWED ALL PATIENTS DIAGNOSED WITH SMAD. THE STUDY WAS DIVIDED INTO 2 GROUPS ENDOVASCULAR GROUP AND MEDICAL MANAGEMENT GROUP. THE TOTAL NUMBER OF PATIENTS IN THE ENDOVASCULAR GROUP IS 37 PATIENTS, WITH 34 PATIENTS SUCCESSFULLY TREATED WITH STENTING AND STENTING FAILED IN 5 PATIENTS. STENTING WAS ABANDONED IN FIVE PATIENTS BECAUSE THE GUIDEWIRE COULD NOT BE NAVIGATED INTO THE DISTAL TRUE LUMEN IN THREE PATIENTS AND BECAUSE THE ANGIOGRAPHY SHOWED UNSATISFACTORY DISTAL OUTFLOW FROM THE ARTERY IN THE OTHER TWO PATIENTS. FOUR MEDTRONIC STENTS WERE USED IN THE ENDOVASCULAR GROUP; EVERFLEX, PROTEGE RX, PROTEGE GPS AND COMPLETE SE. OVERALL, THERE WERE NO SMAD-RELATED DEATHS OR MESENTERIC ARTERY RUPTURES. NINE PATIENTS HAD A RECURRENCE OF ABDOMINAL PAIN, FOUR OF THOSE ARE IN THE ENDOVASCULAR GROUP. THERE WERE SIX REINTERVENTION CASES FOR SMAD, ONE FOR STENT RELATED DISSECTION IN THE OSTIUM OF THE MESENTERIC ARTERY. 8 MONTHS AFTER THE FIRST ENDOVASCULAR TREATMENT, THREE FOR ANEURYSM FORMATION IN THE ENDOVASCULAR GROUP. NO SIGNIFICANT DIFFERENCE WAS DETECTED BETWEEN THE GROUPS. THERE WERE MORE CASES OF COMPLETE OR PARTIAL REMODELING IN THE ENDOVASCULAR GROUP AND MORE UNCHANGED DISSECTIONS SHOWN IN RADIOLOGICAL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1087668 PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention