BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM

    MDR report key: 8174036 · Received December 18, 2018

    Report

    Report Number
    2183870-2018-00580
    Event Type
    Injury
    Date Received
    December 18, 2018
    Date of Event
    December 12, 2018
    Report Date
    January 31, 2019
    Manufacturer
    COVIDIEN
    Product Code
    NIO
    PMA / PMN Number
    P030045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. ALL BALLOON FRAGMENTS WERE REMOVED FROM THE PATIENT USING A GOOSENECK SNARE, SURGERY WAS NOT REQUIRED. EVALUATION AND IMAGE ANALYSIS SUMMARY: FIVE PHOTOGRAPHIC IMAGES WERE RECEIVED. THE FIRST IMAGE IS OF THE DISTAL TIP AND BALLOON CHAMBER ON A GUIDEWIRE. THE BALLOON CHAMBER MATERIAL EXHIBITS RADIAL AND LONGITUDINAL TEARING. THE BALLOON CHAMBER MATERIAL IS PULLED OVER THE DISTAL TIP. THE INNER GUIDEWIRE LUMEN EXHIBITS ACCORDION FOLDING. ACCORDION FOLDING HAPPENS WHEN THE LUMEN IS UNDER TENSILE TENSION AND THE TENSION IS SUDDENLY RELEASED. THE SECOND IMAGE IS OF THE DISTAL TIP AND BALLOON CHAMBER ON A GUIDEWIRE. THE BALLOON CHAMBER MATERIAL IS BEING PINNED DOWN WITH A GLOVED THUMB. THE DISTAL RADIOPAQUE MARKER BAND IS JUST VISIBLE AT THE BALLOON CHAMBER BOND. THE THIRD IMAGE IS A DIFFERENT ANGLE OF THE DISTAL ASSEMBLY ON THE GUIDEWIRE. THE FOURTH PHOTOGRAPH IS OF A CINE IMAGE. DUE TO THE QUALITY AND CLARITY OF THE IMAGE IT IS NOT POSSIBLE TO DETERMINE IF THE STENT IS PRESENT IN THE IMAGE. THE IMAGE APPEARS TO BE OF A PORTION OF THE BALLOON ON A GUIDEWIRE IN THE PATIENT¿S PELVIS REGION. THE FIFTH IMAGE IS OF THE FULLY DEPLOYED STENT. DUE TO THE QUALITY AND CLARITY OF THE IMAGE IT IS NOT POSSIBLE TO SEE THE STENT STRUTS. IT APPEARS THAT A CATHETER IS IN THE IMAGE AND WITHIN THE STENT. THE CATHETER DOES NOT EXHIBIT ANY RADIOPAQUE MARKER BANDS. DUE TO THE QUALITY AND CLARITY IT IS NOT POSSIBLE TO IDENTIFY THE CATHETER. THE VISI-PRO BALLOON-EXPANDABLE BILIARY STENT SYSTEM WAS RECEIVED FOR EVALUATION ALONG WITH A SMALL ZIPLOCK CLOSURE POUCH WITH A VIAL, AND A SEALED SPECIMEN POUCH WITH A NESTED SERIES OF SEALED STERILIZATION POUCHES. NO ANCILLARY DEVICES FROM THE PROCEDURE WERE RECEIVED FOR EVALUATION. THE VIAL RETURNED CONTAINED THREE COMPONENTS OF THE VISI-PRO DEPLOYMENT CATHETER: BALLOON CHAMBER MATERIAL, INNER GUIDEWIRE LUMEN, AND DISTAL TIP. APPROXIMATELY 50MM OF THE 80MM LENGTH BALLOON CHAMBER WAS RECEIVED. APPROXIMATELY 30MM OF BALLOON CHAMBER WERE NOT RECEIVED. THE BALLOON CHAMBER MATERIAL EXHIBITED RADIAL AND LONGITUDINAL TEARING CONSISTENT WITH THE PHOTOGRAPHS RECEIVED. THE DAMAGE TO THE BALLOON CHAMBER MATERIAL IS CONSISTENT WITH REPORTED EVENT. THE SEGMENT OF THE RETURNED INNER GUIDEWIRE LUMEN EXHIBITED ACCORDION FOLDING CONSISTENT WITH BEING UNDER TENSILE FORCES THAT WERE SUDDENLY RELEASED. THE SEPARATION FACES ON BOTH ENDS OF THE SEGMENT CONTAINED TENSILE AND TORSIONAL SEPARATION FACES. THE PROXIMAL GUIDEWIRE LUMEN WAS NOT PRESENT ON THE SEGMENT. THE DISTAL SEGMENT RECEIVED EXHIBITED ACCORDION FOLDING OF THE INNER GUIDEWIRE LUMEN, THE BALLOON CHAMBER DISTAL BOND REMAINED INTACT, THE DISTAL RADIOPAQUE MARKER BAND WAS PRESENT, AND THE DISTAL TIP WAS PRESENT. THE SEALED SPECIMEN TRANSPORT BAG CONTAINED A NESTED SERIES OF SEALED STERILIZATION POUCHES AND THE VISI-PRO CATHETER LOOSELY COILED. THE RETURNED CATHETER DID CONTAIN THE PROXIMAL BALLOON BOND WITH A RADIAL SEPARATION FACE. THE INNER GUIDEWIRE LUMEN ON THE CATHETER EXHIBITED TENSILE AND TORSIONAL STRETCHING. NO PROXIMAL RADIOPAQUE MARKER BAND WAS PRESENT ON THE CATHETER. NOT ALL COMPONENTS OF THE VISI-PRO CATHETER WERE ACCOUNTED FOR. APPROXIMATELY 30MM IN LENGTH OF BALLOON CHAMBER MATERIAL WAS MISSING ALONG WITH THE PROXIMAL RADIOPAQUE MARKER BAND. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A PHYSICIAN ATTEMPTED TO USE A VISIPRO TO TREAT A SEVERELY CALCIFIED LESION IN THE PROXIMAL COMMON ILIAC ARTERY. ARTERY DIAMETER WAS 8MM AND THE VESSEL PRESENTED MODERATE TORTUOSITY. IFU WAS FOLLOWED AND THE DEVICE WAS PEPPED WITH NO ISSUES NOTED. IT WAS REPORTED THAT AFTER TREATING THE VESSEL, THE BALLOON BURST AND THEN DETACHED WHEN THE PHYSICIAN TRIED TO REMOVE THE DEVICE THROUGH THE INTRODUCER. THE PATIENT WAS SENT FOR SURGERY TO REMOVE THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012231 VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC NIO COVIDIEN A721466

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention