BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISI-PRO BALLOON EXPANDABLE PERIPHERAL STENT SYSTEM

    MDR report key: 3232565 · Received July 18, 2013

    Report

    Report Number
    2183870-2013-00171
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 21, 2013
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    PMA / PMN Number
    K061566
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. (B)(4): SINGLE IMAGE RECEIVED.

    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

    THIS PROCEDURE WAS PERFORMED IN (B)(6):THE VISI-PRO STENT WAS ADVANCED USING A GUIDEWIRE. THE STENT BROKE APART IN THE VESSEL. THE BROKEN STENT WAS RETREIVED USING A SNARE. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 1

    A PHOTO IMAGE OF THE STENT IN A SPECIMEN TUBE WAS RECEIVED. THE STENT EXHIBITED RETAINER HOOPS ON BOTH SIDES (PROXIMAL AND DISTAL) INDICATING THAT THE ENTIRE STENT WAS RETRIEVED INTACT. THE STRUT CONFIGURATION WAS SIGNIFICANTLY DAMAGED WITH MOST OF THE DAMAGE CONCENTRATED ON ONE SIDE. THE OTHER SIDE WAS LESS DAMAGED AND SHOWED NO INDICATION THAT IT HAD BEEN SIGNIFICANTLY INFLATED (DEPLOYED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334314 VISI-PRO BALLOON EXPANDABLE PERIPHERAL STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE EV3 INC. PXP35-05-17-135 9486131

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention