BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD

    MDR report key: 8554561 · Received April 26, 2019

    Report

    Report Number
    2183870-2019-00190
    Event Type
    Injury
    Date Received
    April 26, 2019
    Date of Event
    October 10, 2018
    Report Date
    April 26, 2019
    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

    EVENT DATE (DATE OF PUBLISHED ARTICLE) TITLE: ENDOVASCULAR TREATMENT OF PATIENTS WITH ISOLATED MESENTERIC ARTERY DISSECTION ANEURYSM: BARE STENTS ALONE VERSUS STENT ASSISTED COILING EUR J VASC ENDOVASC SURG (2019) 57, 400E406 HTTPS://DOI.ORG/10.1016/J.EJVS.2018.08.057. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A (B)(6) MAN PRESENTED WITH ACUTE ABDOMINAL PAIN THAT HAD LASTED FOR THREE DAYS. SUPERIOR MESENTERIC ARTERIOGRAPHY DEMONSTRATED DISSECTION ANEURYSM AT THE CURVE OF THE SMA, AND THE TRUE LUMEN WAS COMPRESSED. SUPERIOR MESENTERIC ARTERIOGRAPHY DEMONSTRATED COMPLETE RESOLUTION OF THE DISSECTION ANEURYSM IMMEDIATELY AFTER PLACEMENT OF TWO BARE STENTS. CONTRAST ENHANCED COMPUTED TOMOGRAPHY (CT) DEMONSTRATED THAT THE DISSECTION ANEURYSM WAS COMPLETELY THROMBOSED WITH GOOD STENT PATENCY ONE MONTH AFTER TREATMENT. A NEW DISSECTION ANEURYSM WAS OBSERVED ON THE REPEAT CONTRAST ENHANCED CT SCAN PERFORMED SIX MONTHS LATER. SUPERIOR MESENTERIC ARTERIOGRAPHY DEMONSTRATED THE DISSECTION ANEURYSM, AND COMPLETE RESOLUTION OF THE DISSECTION ANEURYSM WAS ACHIEVED AFTER COILING VIA THE STENT MESH USING A MICROCATHETER. COMPLETE RESOLUTION OF THE DISSECTION ANEURYSM WITH GOOD STENT PATENCY WAS OBSERVED ONE YEAR AFTER TREATMENT. SEVERE STENOSIS OF A BRANCH OF THE SMA WAS ALSO OBSERVED ON SUPERIOR MESENTERIC ARTERIOGRAPHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351244 PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention