BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2543662 · Received April 20, 2012

    Report

    Report Number
    2953200-2012-00827
    Event Type
    Death
    Date Received
    April 20, 2012
    Report Date
    March 27, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (DEATH, ENDOLEAK, OCCLUSION); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (LIKELY ANATOMY RELATED). EVALUATION, CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (LIKELY ANATOMY RELATED).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE WHICH IS SUMMARIZED AS FOLLOWS. GENDER DIFFERENCES IN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR WITH THE ANEURX STENT GRAFT, YEHUDA G. WOLF, J VASC SURG 2002;35:882-6. THE STENT GRAFTS WERE IMPLANTED BETWEEN (B)(6) 1996 AND (B)(6) 2001. DURING A RETROSPECTIVE STUDY OF 378 PATIENTS TREATED FOR AAA COMPLICATIONS, 27 TREATED WITH TALENT, THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: DEATH, RE-INTERVENTION, TYPE I ENDOLEAK, TYPE III ENDOLEAK, ILIAC OCCLUSION, ACCESS DIFFICULTIES. RESULTS: WOMEN CONSTITUTED 17% OF PATIENTS CONSIDERED FOR EVAR. THEIR ELIGIBILITY RATE (49%) DID NOT DIFFER SIGNIFICANTLY FROM THAT OF MEN (57%), AND THEY CONSTITUTED 14% OF PATIENTS WHO UNDERWENT EVAR (26/189). WOMEN WHO UNDERWENT EVAR WERE OLDER ((B)(6); P <(><<)> .005) WITH A HIGHER RATE OF CHRONIC OBSTRUCTIVE LUNG DISEASE (50% VERSUS 28%; P <(><<)> .05). MAXIMAL ANEURYSM DIAMETER (57.2 _ 10.9 MM VERSUS 57.8 _ 9.4 MM; NOT SIGNIFICANT) DID NOT DIFFER BETWEEN MEN AND WOMEN. MEAN DIAMETERS OF THE PROXIMAL NECK (20.4 _ 2.3 MM VERSUS 22.3 _ 2.0 MM; P .01), COMMON ILIAC ARTERIES (11.4 _ 1.2 MM VERSUS 13.5 _ 3.6 MM; P <(><<)> .001), AND EXTERNAL ILIAC ARTERIES (7.9 _ 0.7 MM VERSUS 9.4 _ 1.4 MM; P <(><<)> .001) WERE ALL SMALLER IN WOMEN, AND ABDOMINAL AORTIC ANEURYSM/NECK DIAMETER RATIO WAS LARGER (2.82 _ 0.59 VERSUS 2.60 _ 0.49; P <(><<)> .05). THE LENGTH OF THE PROXIMAL AORTIC NECK WAS SHORTER IN WOMEN (20.7 _ 8.2 MM VERSUS 24.5 _ 11.8 MM; P <(> <<)> .05). WOMEN HAD SIGNIFICANTLY MORE INTRAOPERATIVE COMPLICATIONS (31% VERSUS 13%; P <(><<)> .05), PRIMARILY RELATED TO ARTERIAL ACCESS, AND NEEDED MORE FREQUENT ARTERIAL RECONSTRUCTION (42% VERSUS 21%; P <(><<)> .05), WITHOUT A DIFFERENCE IN POSTOPERATIVE MORTALITY RATE (0/26 VERSUS 2/163; NOT SIGNIFICANT) AND COMPLICATION RATE (23% VERSUS 20%: NOT SIGNIFICANT). DURING A FOLLOW-UP PERIOD OF 13.8 _ 11.7 MONTHS, NO GENDER-RELATED DIFFERENCE WAS FOUND IN SURVIVAL RATE, ENDOLEAK RATE, OR RE-INTERVENTION RATE OR IN THE RATE OF CHANGE IN ANEURYSM DIAMETER OR VOLUME. CONCLUSION: ELIGIBILITY RATES OF WOMEN FOR EVAR ARE SIMILAR TO THOSE OF MEN. WOMEN ARE AT AN INCREASED RISK FOR ACCESS-RELATED COMPLICATIONS DURING EVAR, BUT OUTCOME IS EQUIVALENT TO THAT OF MEN.

    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 SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention