BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2547253 · Received April 24, 2012

    Report

    Report Number
    2953200-2012-00855
    Event Type
    Death
    Date Received
    April 24, 2012
    Report Date
    March 29, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    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 (DEATH, ENDOLEAK, VESSEL 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: ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR: DOES GENDER MATTER? SERGIO M. SAMPAIO, ANN VASC SURG 2004; 18: 653-660. DURING A RETROSPECTIVE STUDY OF 241 PATIENTS TREATED FOR AAA COMPLICATIONS, 175 TREATED WITH ANEURX AND 1 TREATED WITH TALENT BETWEEN (B)(6)1996 AND (B)(6) 2003, THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: ILIAC ACCESS ANGIOPLASTY, UNI-ILIAC CONVERSION, ACCESS COMPLICATIONS, TYPE I ENDOLEAK, CUFF REQUIRED, TYPE II ENDOLEAK, TYPE III ENDOLEAK, PERIOPERATIVE DEATH, FEM-FEM BYPASS, NECK DILATATION, ANEURYSM EXPANSION, LIMB OCCLUSION. SUBSTANTIAL DIFFERENCES ACROSS GENDERS HAVE BEEN DOCUMENTED FOR THE NATURAL HISTORY AND CLINICAL COURSE OF CARDIOVASCULAR DISEASES. THIS STUDY'S OBJECTIVE IS TO COMPARE PREOPERATIVE CHARACTERISTICS, INTRAOPERATIVE EVENTS, AND POSTOPERATIVE OUTCOMES IN MEN AND WOMEN UNDERGOING ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR). WE HYPOTHESIZED THAT DESPITE GENDER ANATOMIC SPECIFICITIES, EVAR MAY ACHIEVE SIMILAR RESULTS ACROSS GENDERS. WE INCLUDED 241 CONSECUTIVE PATIENTS WHO UNDERWENT ELECTIVE EVAR AT OUR INSTITUTION FROM (B)(6) 1996 THROUGH (B)(6) 2003. DEMOGRAPHIC VARIABLES AND COMORBIDITIES WERE COLLECTED BY CHART REVIEW, AND INTRAOPERATIVE EVENTS WERE FROM SURGICAL NOTES. BASELINE ANATOMIC CHARACTERISTICS WERE EVALUATED ON THE LAST PREOPERATIVE COMPUTED TOMOGRAPHY (CT) SCAN. RADIOLOGIC OUTCOMES WERE EVALUATED ON ALL POSTOPERATIVE CT SCANS, AND CLINICAL FOLLOW-UP INFORMATION WAS ABSTRACTED FROM CHARTS. WOMEN CONSTITUTED 12% (N = 29) OF OUR COHORT AND WERE OLDER THAN MEN ((B)(6) YEARS, P = 0.0003). WHEN COMPARED TO MEN, THEY HAD ANEURYSMS WITH SIMILAR DIAMETER (54.1 VS. 55.5 MM, P = 0.491) BUT NARROWER (23.1 VS 25.5 MM, P = 0.0001) AND SHORTER (18.9 VS. 30.4 MM, P 0.0001) PROXIMAL NECKS. FEMALE ILIAC ARTERIES WERE NARROWER (9.6 VS. 11.4 MM, P = 0.0001), WITH HIGHER CALCIFICATION SCORES (2.5 VS. 2.3, P = 0.047) BUT LOWER TORTUOSITY INDEXES (1.2 VS. 1.3, P = 0.0001). ADDITIONAL ACCESS MANEUVERS WERE MORE FREQUENT IN WOMEN: ILIAC ACCESS ANGIOPLASTY (31% VS. 10.9%, = P = 0.007), UNI-ILIAC CONVERSION (13.8% VS. 1.4%, P = 0.005), AND ILIAC "CHIMNEY" CONDUIT (12.1% VS. 1.2%, P = 0.0001). THERE WAS A TREND TOWARD LONGER FLUOROSCOPY TIME IN WOMEN (34.6 VS. 26.9 MIN, P = 0.056). THE FOLLOWING POSTOPERATIVE OUTCOMES AT 24 MONTHS WERE SIMILAR IN WOMEN AND MEN: FREEDOM FROM ENDOLEAK (63.4% VS. 72.7%, P = 0.74), REINTERVENTION RATE (28% VS. 24.5%, P = 0.878), ANEURYSM SHRINKAGE (24.3% VS. 68.7%, P = 0.199), ANEURYSM EXPANSION (0% VS. 3%, P = 0.213), AND SURVIVAL (92.9% VS. 84.3%, P = 0.341). THERE WAS A TREND TOWARD HIGHER RATES OF NECK DILATION RELATIVE TO PREOPERATIVE DIAMETER IN WOMEN (48.5% VS. 16% AT 12 MONTHS, P = 0.059) AND TOWARD LOWER LIMB PATENCY RATES IN MEN (100% VS. 92.8%, P = 0.098). IN SUM, WOMEN HAVE SHORTER PROXIMAL NECKS AND SMALLER AND MORE CALCIFIED ILIAC ARTERIES, WHICH INCREASES THE NECESSITY OF ACCESS-RELATED ADDITIONAL MANEUVERS. DESPITE BEING OLDER AND HAVING A LESS FAVORABLE ANATOMY, WOMEN CAN EXPECT SIMILAR TECHNICAL AND CLINICAL OUTCOMES AFTER EVAR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention