BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 389473 · Received April 18, 2002

    Report

    Report Number
    2952368-2002-00085
    Event Type
    Malfunction
    Date Received
    April 18, 2002
    Date of Event
    January 24, 2002
    Report Date
    March 20, 2002
    Manufacturer
    MEDTRONIC AVE PERIPHERAL DIVISION
    Product Code
    MIH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 28 MM DIAMETER X 16 MM DIAMETER X 16.5 CM LENGTH ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM IN 2001. THE PT HAS A HISTORY OF RENAL INSUFFICIENCY. IMAGES REC'D BY MEDTRONIC AVE WERE ANALYZED. THE PREOPERATIVE COMPUTERIZED TOMOGRAPHY SCAN OF 2001 REVEALED THAT THE DIAMETER OF THE PROXIMAL NON-ANEURYSMAL AORTIC NECK WAS 21.8-23.7 MM WITH A PROXIMAL NECK SEALZONE LENGTH OF 60.4 MM. THE PROXIMAL NECK ANGULATION WAS REPORTED TO BE 49 DEGREES. POST-OPERATIVE IMAGES OF 2002 REVEALED THAT THE BIFURCATED STENT GRAFT APPEARS TO BE INFOLDED JUST ABOVE THE BIFURCATION WITH NO CHANGE IN THE NECK DIAMETER. ANEURYSM SIZE HAD INCREASED FROM 47 MM PRE-OPERATIVELY TO 49 MM POST-OPERATIVELY. THE GRAFT LIMBS APPEARED TO BE DEPLOYED NORMALLY, AND THE ACHIEVED DISTAL SEALZONES APPEARED TO BE ADEQUATE. BECAUSE OF THE PT'S RENAL INSUFFICIENCY, NO CONTRAST WAS USED DURING IMAGING; THEREFORE, THE PRESENCE OR ABSENCE OF ENDOLEAK COULD NOT BE DETERMINED. MEDICAL MEDIA SYSTEMS CONCLUDED THAT THE CAUSE OF THE INFOLDING COULD NOT BE DETERMINED. THE PT'S STATUS IS UNKNOWN. DESPITE MULTIPLE ATTEMPTS TO OBTAIN INFO, NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE) AAA STENT GRAFT MIH MEDTRONIC AVE PERIPHERAL DIVISION NA M01F750713

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other