BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVANTA V12 COVERED STENT

    MDR report key: 2963897 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00166
    Event Type
    Other
    Date Received
    January 2, 2013
    Report Date
    August 9, 2011
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    JCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORD WAS REVIEWED AND THE PRODUCT MET ITS SPECIFICATION AT THE TIME OF RELEASE TO DISTRIBUTION. PRODUCT COMPLAINTS WERE REVIEWED AND THERE WERE NO OTHER REPORTS OF PRODUCT PROBLEMS FOR THE LOT. BASED ON THE INVESTIGATION AND RECORDS REVIEWS, A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DOCTOR TRIED TO IMPLANT V12 AND IT DIDN'T WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1423 ADVANTA V12 COVERED STENT COVERED STENT JCT ATRIUM MEDICAL CORP. 85336 10728928

    Patients

    Seq Age Sex Outcome Treatment
    1