BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V12 COVERED STENT

    MDR report key: 3893951 · Received June 12, 2014

    Report

    Report Number
    1219977-2014-00188
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 26, 2014
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DYF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE IN THE PROCESS OF PERFORMING THE INVESTIGATION AND WILL SUBMIT THE FOLLOW-UP REPORT ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    REPORT RECEIVED THAT A PT HAD A RUPTURED AORTIC ANEURYSM AT THE RIGHT OF THE RENAL ARTERY (SINGLE KIDNEY) AND WITH RETROPERITONEAL HEMATOMA. THE STENT DISLODGED FROM THE BALLOON BEYOND THE SHEATH WITH IN THE BRACHIAL ARTERY RESULTING IN THE NEED TO PULL OUT THE BALLOON INTO THE STENT AND TO DEPLOY IT IN THE BRACHIAL ARTERY (BRACHIAL APPROACH). OTHER CATHETERS COULD NOT CROSS THE AREA. PROCEDURE WAS COMPLETED WITHOUT REVASCULARIZATION OF THE RIGHT RENAL ARTERY. THE PT DEVELOPED ISCHEMIC RENAL FAILURE NECESSITATING HEMODIALYSIS, SEPTICEMIA AND WAS PLACED ON RESPIRATORY (VENTILATOR) SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348685 V12 COVERED STENT PTFE COVERED STENT DYF ATRIUM MEDICAL CORP. 85337 20335

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention