BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2873052 · Received December 13, 2012

    Report

    Report Number
    2953200-2012-02427
    Event Type
    Death
    Date Received
    December 13, 2012
    Report Date
    November 18, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (INFECTION, OCCLUSION, DEATH). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (NARROW AORTIC BIFURCATION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (AORTIC NECK HAD ELONGATED AND DILATED).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION DURING A CONFERENCE APPROXIMATELY ONE MONTH AGO. CHALLENGES OF A NARROW AORTIC BIFURCATION INCLUDE DIFFICULT GATE CANNULATION, LIMB COLLAPSE AND AORTIC DISRUPTION. AUI ENDOGRAFTS WITH FEM-FEM BYPASS WERE TRADITIONALLY USED IN THESE PATIENTS, HOWEVER, COMPLICATIONS INCLUDED WOUND INFECTION (11%), GRAFT INFECTION (3%) AND 5 YEAR PATENCY OF 83%. EXPERIENCE FROM 2000-2011 IN 112 PATIENTS WITH DISTAL AORTIC NECKS <(><<)> 18 MM WAS PRESENTED, INCLUDING A HIGH NUMBER OF FEMALES. THE MEAN INNER DISTAL NECK DIAMETER WAS 14 ± 2 MM; 34 HAD A DIAMETER <(><<)> 14 MM. SIX PATIENTS WERE TREATED WITH AUI AND 106 WITH A BIFURCATED GRAFT, USING A VARIETY OF GRAFTS. KISSING BALLOON TECHNIQUE WAS USED IN ALMOST ALL, AND STENTS WERE PLACED IN 21. EARLY MORTALITY WAS 0.9% AND THERE WERE NO CONVERSIONS. OVER A FOLLOW-UP OF 32 ± 18 MONTHS, 4 LIMBS DEVELOPED STENOSIS OR OCCLUSION. THE PRIMARY PATENCY WAS 97% AT TWO YEARS, AND ESTIMATED FREEDOM FROM RE-INTERVENTION WAS 92% AT 5 YEARS. LESSONS LEARNED INCLUDE THE IMPORTANCE OF DILATING THE GATE BEFORE ADVANCING THE LIMB, DILATING THE BIFURCATION WITH KISSING BALLOON TECHNIQUE, AND USE OF STENTING AND BRACHIAL ACCESS AS NEEDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1