BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 3894016 · Received June 25, 2014

    Report

    Report Number
    2953200-2014-01272
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    January 1, 2013
    Report Date
    May 29, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OVERSIZING OF GRAFT. EXACT DATE OF EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    (DR. (B)(6) - APPROVED). AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY IS UNKNOWN. IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT PRESENTED EMERGENTLY WITH RUPTURE SYMPTOMS. ANOTHER MANUFACTURER'S DEVICE WAS IMPLANTED TO RESOLVE A TYPE III SEPARATION ENDOLEAK BETWEEN THE BIFURCATE AND AORTIC CUFF. THE PHYSICIAN BELIEVES THE SEPARATION WAS CAUSED BY MIGRATION OF THE BIFURCATE. THE LEAK WAS RESOLVED. APPROXIMATELY A YEAR LATER, THE PATIENT PRESENTED EMERGENTLY WITH A CONTAINED ANEURYSM RUPTURE. AN ANGIOGRAM REVEALED A TYPE III SEPARATION ENDOLEAK BETWEEN THE BIFURCATE AND THE OTHER MANUFACTURER'S DEVICE. THE PHYSICIAN BELIEVES THE SEPARATION WAS DUE TO EXTREME OVERSIZING. A 36X16X124 STENT GRAFT WAS PLACED DISTAL TO THE RIGHT RENAL ARTERY AND THE GATE WAS OPENED PROXIMAL TO THE FLOW DIVIDER OF THE BIFURCATE. AFTER GATE CANNULATION, A 16X16X93 STENT GRAFT WAS EXTENDED INTO THE LIMB OF THE ORIGINAL ANEURX. AN ANGIOGRAM WAS PERFORMED, AND THE ENDOLEAK WAS CONFIRMED TO BE RESOLVED. IT WAS ALSO NOTED THAT THERE WAS AN IRREGULARITY IN THE DISTAL LEFT COMMON ILIAC ARTERY, AND THE PHYSICIAN PLACED A 16X13X93 INTO THE LEFT EXTERNAL ILIAC ARTERY, INTENTIONALLY COVERING THE LEFT INTERNAL ILIAC ARTERY. A FINAL ANGIOGRAM SHOWED NO FURTHER ISSUES. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371667 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR 206601

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention