BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISI-PRO BALLOON EXPANDABLE BILIARY STENT SYSTEM

    MDR report key: 3205806 · Received July 3, 2013

    Report

    Report Number
    2183870-2013-00160
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 6, 2013
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    PMA / PMN Number
    K061566
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN (B)(4) LOCATION, FOLLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN. A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING.

    Description of Event or Problem · 1

    RENAL STENTING CASE. ACCESS WAS OBTAINED VIA THE RIGHT SIDE GROIN AND A 6F LONG SHEATH WAS PLACED. THE PHYSICIAN USED A .035 WIRE AND QUICKCROSS TO CANULATE RENAL STENOSIS. THE STENOSIS WAS 50% OR GREATER AND CALCIFIED. THERE WAS NO PREDILATION AND THE VISI-PRO WAS INSERTED. WHEN ATTEMPTING TO CROSS THE LESION AT THE ORIGIN OF THE RENAL ARTERY THE VISI-PRO STENT APPEARED TO FLARE AND CAME OFF BALLOON CATHETER. ACCESS OBTAINED ON LEFT SIDE AND A SNARE WAS USED TO REMOVE THE VISI-PRO STENT. THE ENTIRE STENT WAS RECOVERED AND ANOTHER STENT WAS DEPLOYED SUCCESSFULLY.

    Description of Event or Problem · 1

    DEVICE EVALUATION: THE VISI-PRO BALLOON-EXPANDABLE BILIARY STENT SYSTEM WAS RECEIVED FOR EVALUATION WITH THE CATHETER IN ONE BIO-HAZARD BAG AND THE STENT IN ANOTHER BIO-HAZARD BAG. THE STENT WAS FRACTURED INTO TWO PIECES. ONE STENT FRAGMENT WAS 1/2 CELL AND WAS SEVERELY DEFORMED. THE OTHER FRAGMENT WAS 4 CELLS AND THE 1 CELLS ADJACENT TO THE FRACTURE FACE WERE SEVERELY ELONGATED. THE STRUTS AT THE OTHER END OF THE LONGER SEGMENT EXHIBITED FOLD-OVER DAMAGE. THE BALLOON CHAMBER WAS IN PRE-INFLATION PROFILE (TIGHT-WRAPPED AND STENT WITNESS MARKS). THE WITNESS MARKS INDICATE THAT THE STENT HAD BEEN CRIMPED WELL-CENTERED BETWEEN THE CATHETERS MARKER BANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305964 VISI-PRO BALLOON EXPANDABLE BILIARY STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE EV3 INC. PXB35-06-17-080 9548431

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention PARAMOUNT MINI STENT| 6F ANSEL LONG SHEATH| 25CM GOOSENECK SNARE