BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AAA

    MDR report key: 4690683 · Received April 14, 2015

    Report

    Report Number
    2953200-2015-00709
    Event Type
    Injury
    Date Received
    April 14, 2015
    Date of Event
    December 17, 2014
    Report Date
    March 23, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; AORTOILIAC ELONGATION AFTER EVAR. VENITA CHANDRA, MARTIN ROUER, TRIT GARG, DOMINIK FLEISCHMANN, MATTHEW MELL. ANNALS OF VASCULAR SURGERY (2015), DOI: 10.1016/J.AVSG.2014.12.041. A TALENT AAA STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSM. DURING THE RETROSPECTIVE STUDY THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: TYPE IA ENDOLEAK, TYPE II ENDOLEAK. OBJECTIVES AORTOILIAC ELONGATION AFTER ENDOVASCULAR AORTIC ANEURYSM REPAIR (EVAR) IS NOT WELL STUDIED. WE SOUGHT TO ASSESS LONG TERM MORPHOLOGIC CHANGES AFTER EVAR, AS WELL AS IDENTIFY POTENTIALLY MODIFIABLE FACTORS ASSOCIATED WITH SUCH CHANGE METHODS AN IRB APPROVED RETROSPECTIVE REVIEW WAS CONDUCTED FOR 88 CONSECUTIVE PATIENTS WHO UNDERWENT EVAR AT A SINGLE ACADEMIC CENTER FROM 2003-2007 AND WHO ALSO HAD AT LEAST TWO FOLLOW UP CT ANGIOGRAMS (CTAS) AVAILABLE FOR REVIEW UP TO 5 YEARS AFTER SURGERY. STANDARDIZED CENTERLINE AORTIC LENGTHS AND DIAMETERS WERE OBTAINED ON AQUARIUS INTUITION 3D WORKSTATION (TERARECON INC., (B)(4)) ON POST-OPERATIVE AND ALL AVAILABLE FOLLOW-UP CTAS. RELATIONSHIPS TO AORTIC ELONGATION WERE DETERMINED USING WILCOXON RANK-SUM TEST OR LINEAR REGRESSION (STATA VERSION 12.1, (B)(6)). CHANGES IN LENGTH OVER TIME WERE DETERMINED BY MIXED EFFECTS ANALYSIS (SAS VERSION 9.3, CARY, NC). RESULTS THE STUDY COHORT WAS COMPOSED OF MOSTLY MEN (88%), WITH A MEAN AGE OF (76+/-8) AND A MEAN FOLLOW UP OF 3.2 YEARS (RANGE: 0.4-7.5 YEARS). FIFTY SEVEN PERCENT OF PATIENTS (N=50) HAD DEVICES WITH SUPRARENAL FIXATION AND 43% (N=38) HAD NO SUPRARENAL FIXATION. SIGNIFICANT LENGTHENING WAS OBSERVED OVER THE STUDY PERIOD IN THE AORTOILIAC SEGMENTS, BUT NOT IN THE ILIOFEMORAL SEGMENTS. AORTOILIAC ELONGATION OVER TIME WAS NOT ASSOCIATED WITH SEX (P=0.3), HYPERTENSION (P=0.7), CORONARY ARTERY DISEASE (P=0.3), 45 DIABETES (P=0.3), OR TOBACCO USE (P=0.4), BUT WAS ASSOCIATED WITH THE USE OF STATINS (P=0.03), AND THE PRESENCE OF COPD (P=0.02). SIGNIFICANT AORTIC LENGTHENING WAS ASSOCIATED WITH INCREASED TYPE I ENDOLEAKS (P=.03) AND RE-INTERVENTIONS (P=.03). OVER THE STUDY PERIOD FOUR DIFFERENT DEVICES WERE USED; ZENITH (COOK MEDICAL INC., (B)(4)), TALENT (MEDTRONIC, (B)(4)), ANEURYX (MEDTRONIC) AND EXCLUDER (W. L. GORE AND ASSOCIATES INC., (B)(4)). AFTER ADJUSTING FOR DIFFERENCES IN PROXIMAL LANDING ZONE SIGNIFICANT DIFFERENCES IN AORTIC LENGTHENING OVER TIME WERE OBSERVED BY DEVICE TYPE (P=0.02). CONCLUSIONS SIGNIFICANT AORTOILIAC ELONGATION WAS OBSERVED AFTER EVAR. SUCH MORPHOLOGIC CHANGES MAY IMPACT LONG TERM DURABILITY OF EVAR, WARRANTING FURTHER INVESTIGATION INTO FACTORS ASSOCIATED WITH THESE MORPHOLOGIC CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247174 TALENT AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention