BEUDAMED
    FDA Adverse Event Death Summary report: N

    VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM

    MDR report key: 6957248 · Received October 18, 2017

    Report

    Report Number
    2183870-2017-00454
    Event Type
    Death
    Date Received
    October 18, 2017
    Date of Event
    August 28, 2017
    Report Date
    October 17, 2017
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    K061566
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AVERAGE AGE. MAJORITY GENDER. EVENT DATE IS LITERATURE ARTICLE PUBLISHED DATE SELF-EXPANDING VERSUS-EXPANDABLE STENTS FOR ILIAC ARTERY OCCLUSIVE DISEASE JACC: CARDIOVASCULAR INTERVENTIONS 2017; 10:1694¿704 HTTP://DX.DOI.ORG/10.1016/I.JCIN.2017.05.015. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A STUDY WAS CARRIED OUT ON 660 PATIENTS, 340 PATIENTS WERE TREATED WITH PROTÉGÉ EVERFLEX SELF-EXPANDING (SE) STENT, 320 PATIENTS WERE TREATED WITH VISI-PRO BALLOON-EXPANDABLE (BE) STENT IN THE COMMON EXTERNAL ILIAC ARTERY. EVALUATIONS WERE PERFORMED AT 6 AND 12 MONTHS, PATIENTS PRESENTED WITH RESTENOSIS, TARGET LESION RESTENOSIS (TLR), CEREBRAL ANEURYSM, CARDIOGENIC SHOCK, MYOCARDIAL INFARCTION, PNEUMONIA, SEPSIS, LIMB AMPUTATIONS, STROKE, ACCESS SITE PERFORATION, IN-STENT RESTENOSIS, OCCLUSION. IN THE SE GROUP, 2 PATIENTS DIED. ONE OF THEM DUE TO MYOCARDIAL INFARCTION AT 12 MONTHS AND THE OTHER FOR UNKNOWN REASONS AT 3 MONTHS. IN THE BE GROUP 8 PATIENTS DIED: 2 OF THEM FROM MYOCARDIAL INFARCTION AT 5 MONTHS OR CARDIOGENIC SHOCK AT 6 MONTHS, AND 4 OF THEM FROM CEREBRAL ANEURYSM, PNEUMONIA, SEPSIS, OR MULTIPLE MYELOMA WITHIN 12 MONTHS. TWO PATIENTS FROM THE BE GROUP DIED FOR UNKNOWN REASONS. IN 4 SE PATIENTS, A DISTAL EMBOLIZATION OCCURRED AND COULD BE RESOLVED DURING THE INDEX PROCEDURE. THREE OF THE PATIENTS WERE TREATED DUE TO AN OCCLUSION AND 1 OF THEM WAS TREATED DUE TO AN IN-STENT RESTENOSIS. THE STUDY CONCLUDED THAT THE TREATMENT OF ILIAC ARTERY OCCLUSIVE DISEASE WITH SE AS COMPARED TO BE STENT RESULTED IN A LOWER 12-MONTH RESTENOSIS RATE AND A SIGNIFICANTLY REDUCED TLR RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736826 VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death