BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISI-PRO BALLOON EXPANDABLE BILIARY STENT SYSTEM

    MDR report key: 3150561 · Received June 6, 2013

    Report

    Report Number
    2183870-2013-00137
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 7, 2013
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    PMA / PMN Number
    K061566
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT: MODEL #694758, IMPLANTABLE TACHY LEAD, IMPLANT DATE: (B)(6) 2001; MODEL #419688, IMPLANTABLE PACING LEAD, IMPLANT DATE: (B)(6) 2010; MODEL #507645, IMPLANTABLE PACING LEAD, IMPLANT DATE: (B)(6) 2007. (B)(4).

    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

    THE PHYSICIAN PERFORMED A BILATERAL CUTDOWN AND SHEATHS WERE PLACED IN EACH FEMORAL ARTERY. A AAA GRAFT WAS PLACED AND THEN BALLOONED. THE LEFT RENAL ARTERY WAS DETERMINED TO BE COMPROMISED. THE LEFT RENAL ARTERY WAS WIRED AND A 5X27 VISIPRO WAS ADVANCED. AT THAT POINT EITHER THE AAA GRAFT OR THE TIGHT RENAL STENOSIS DISPLACED THE STENT. THE STENT WAS RETRIEVED USING A 25MM SNARE.

    Description of Event or Problem · 1

    DEVICE EVALUATION: THE VISI-PRO BALLOON-EXPANDABLE BILIARY STENT SYSTEM WAS RECEIVED FOR EVALUATION WITHOUT ANY ANCILLARY DEVICES. THE STENT WAS NOT RECEIVED. MICROSCOPIC EXAMINATION OF THE BALLOON REVEALED WITNESS MARKS OF THE ENTIRE STENT AND ALSO PROVIDED THE INDICATION THAT THE STENT WAS WELL-CENTERED BETWEEN THE BALLOON MARKERBANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251630 VISI-PRO BALLOON EXPANDABLE BILIARY STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE EV3 INC. PXB35-05-27-080 9530938

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention 25MM GOOSENECK SNARE