BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX EXTENDER CUFF - OUS (FLEXIBLE)

    MDR report key: 303979 · Received November 13, 2000

    Report

    Report Number
    2953738-2000-00067
    Event Type
    Injury
    Date Received
    November 13, 2000
    Date of Event
    April 26, 2000
    Report Date
    August 16, 2000
    Manufacturer
    MEDTRONIC AVE PERIPHERAL DIVISION
    Product Code
    MIH
    Removal / Correction Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ANEURX BIFURCATED STENT GRAFT, 26MM X 15MM DIAMETER X 16.5CM LENGTH, WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM IN 1998. DURING THE PROCEDURE, THE STENT GRAFT WAS INADVERTENTLY PULLED DOWN INTO THE ANEURYSMAL SAC, RESULTING IN AN INEFFECTIVE PROXIMAL SEAL WHICH WAS RESOLVED WITH THE ADDITION OF TWO 28MM DIAMETER X 3.75 CM LONG EXTENDER CUFFS. INSUFFICIENT OVERLAPPING OF THE PROXIMAL EXTENSION CUFFS WAS KNOWN AT THE TIME OF THE PROCEDURE. THE PT CONTINUED TO BE FOLLOWED CLINICALLY AND UNDERWENT REPEAT ANGIOGRAPHY APPROXIMATELY ONE YEAR LATER, WHICH REVEALED THAT THE TWO PROXIMAL EXTENSION CUFFS HAD "MOVED APART." IN 2000, A 28MM DIAMETER X 6CM LENGTH THORACIC STENT GRAFT WAS SUCCESSFULLY IMPLANTED TO RESOLVE THE GAP BETWEEN THE CUFFS. THE PT IS REPORTEDLY DOING FINE. THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT. A SEPARATE MEDWATCH REPORT IS FILED FOR THE BIFURCATED STENT GRAFT (2953738-2000-00044). EACH EXTENDER CUFF USED IN THIS EVENT WILL HAVE A SEPARATE MEDWATCH REPORT FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX EXTENDER CUFF - OUS (FLEXIBLE) AAA STENT GRAFT MIH MEDTRONIC AVE PERIPHERAL DIVISION NA M9810106

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention