BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISI PRO

    MDR report key: 4101270 · Received September 19, 2014

    Report

    Report Number
    2183870-2014-00237
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    PLYMOUTH
    Product Code
    FGE
    PMA / PMN Number
    K061566
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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

    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 ATTEMPTED TO ADVANCE THE VISI-PRO STENT INTO THE LEFT COMMON ILIAC. WHILE ADVANCING, THE STENT APPEARED TO BECOME DISLODGED FROM THE MOUNTED BALLOON PLATFORM. THEREFORE, THE PHYSICIAN DEPLOYED THE STENT IN A DIFFERENT LOCATION, IN THE EXTERNAL ILIAC. THE PHYSICIAN THEN SUCCESSFULLY DEPLOYED A DIFFERENT STENT IN THE PROPER LESION LOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582575 VISI PRO CATHETER, BILIARY, DIAGNOSTIC, FGE PLYMOUTH PXB35-07-57-135 9693738

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R