BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM

    MDR report key: 6817957 · Received August 24, 2017

    Report

    Report Number
    2183870-2017-00359
    Event Type
    Malfunction
    Date Received
    August 24, 2017
    Date of Event
    July 26, 2017
    Report Date
    September 6, 2017
    Manufacturer
    COVIDIEN
    Product Code
    FGE
    PMA / PMN Number
    K061566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGE ANALYSIS SUMMARY: THE VISI-PRO BALLOON-EXPANDABLE BILIARY STENT SYSTEM WAS NOT RECEIVED FOR EVALUATION. ELEVEN IMAGES WERE RECEIVED THAT INCLUDE CT SCANS, CINES, AND PHOTOGRAPHIC IMAGES OF PROCEDURAL NOTES. CT IMAGE 1 SHOWS BLOOD FLOW TO THE AORTIC AND AN ARROW POINTS TO THE LOCATION OF THE VISI-PRO STENT ON THE LEFT SIDE OF THE IMAGE. DUE TO THE QUALITY AND CLARITY OF THE IMAGE A FRACTURE OF THE VISI-PRO STENT CANNOT BE CONFIRMED. CT IMAGES 2-5 SHOW WHAT APPEARS TO BE A VISI-PRO STENT IN A BEND IN THE CELIAC ARTERY. THE QUALITY AND CLARITY OF THE IMAGES DOES NOT ALLOW FOR POSITIVE IDENTIFICATION OF THE STENT AS A VISI-PRO STENT. STENT CELL STRUCTURE/LATTICE IS NOT CLEARLY VISIBLE IN THE IMAGE. BY COMPARING THE WIDTH TO THE LENGTH VISIBLE IN THE IMAGE THE STENT HAS A HIGH PROBABILITY OF BEING A 6MM BY 17MM VISI-PRO STENT. DUE TO THE QUALITY AND CLARITY OF THE IMAGES A FRACTURE OF THE VISI-PRO STENT CANNOT BE CONFIRMED. CINE IMAGES 6 ALONG WITH CT IMAGES 7-8 SHOW TWO STENTS PROTRUDING FROM THE AORTA. THE STENT ABOVE THE LOWER STENT IS THE VISI-PRO STENT IN THE CELIAC ARTERY BASED ON ITS LOCATION AND PROCEDURAL NOTES PROVIDED. THE CINE IMAGES DO NOT PROVIDE ENOUGH CLARITY TO VIEW THE STENT CELL LATTICE. THE STENT APPEARS TO BE IN A BEND IN THE CELIAC ARTERY. DUE TO THE QUALITY AND CLARITY OF THE IMAGES A FRACTURE OF THE VISI-PRO STENT CANNOT BE CONFIRMED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PHYSICIAN IMPLANTED A VISI-PRO BALLOON EXPANDABLE STENT ON (B)(6) TO TREAT A SEVERELY CALCIFIED LESION (6-10MM) IN PROXIMAL LOCATION IN THE BILIARY ARTERY OF DIAMETER 5.5MM. LESION EXHIBITED 80-90% STENOSIS. PROCEDURE PROCEEDED AS NORMAL WITHOUT ISSUE. POST DEPLOYMENT AORTOGRAM CONFIRMED THAT THERE WAS GOOD FLOW IN CELIAC ARTERY WITHOUT ANY EVIDENCE OF ANY RESIDUAL STENOSIS AND BETTER FLOW. IT WAS REPORTED THAT THE POST-OPERATIVE CT SCAN INDICATED A FRACTURED STENT IN THE CELIAC ARTERY. PHYSICIAN HAS INDICATED THAT THERE IS NO COMPLICATION DUE TO THIS FRACTURE AND THE PATIENT HAS GAINED 10 LBS SINCE LAST MONTH AND THAT THE PROCEDURE WAS A SUCCESS. PHYSICIAN HAS NO FUTURE TREATMENT PLANS FOR THIS PATIENT AS SHE IS DOING WELL AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596457 VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE COVIDIEN A094615

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other