BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AAA STENT GRAFT

    MDR report key: 6337784 · Received February 16, 2017

    Report

    Report Number
    2953200-2017-00216
    Event Type
    Injury
    Date Received
    February 16, 2017
    Date of Event
    January 20, 2016
    Report Date
    January 27, 2017
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED ¿PROGRESSION TO STAGE 3 AND 4 CHRONIC KIDNEY DISEASE AND RISK FACTOR STRATIFICATION FOLLOWING ENDOVASCULAR AORTIC ANEURYSM REPAIR SOMALA MOHAMMED, PANAGIOTIS KOUGIAS, TAHER M MANDVIWALA, NEAL R BARSHES, AND GEORGE T PISIMISIS (VASCULAR) DOI: 10.1177/1708538116628707. TALENT, ENDURANT AND ANEURX STENT GRAFT SYSTEMS WERE IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL ANEURYSM REPAIR BETWEEN 2006 AND 2012. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: RENAL INSUFFICIENCY ABSTRACT BACKGROUND: RISK OF PROGRESSION TO VARIOUS STAGES OF CHRONIC KIDNEY DISEASE (CKD) AFTER ENDOVASCULAR AORTIC ANEURYSM REPAIR (EVAR) IS UNKNOWN. THIS STUDY ESTIMATES PROGRESSION RATES TO STAGE 3 AND 4 CKD AFTER EVAR AND IDENTIFIES POTENTIAL PREDICTORS FOR PROGRESSION. METHODS: EVAR CASES (2006¿2012) WERE RETROSPECTIVELY REVIEWED. FREEDOM OF PROGRESSION TO CKD WAS ESTIMATED USING KAPLAN¿MEIER ANALYSIS, AND PREDICTORS FOR PROGRESSION WERE IDENTIFIED USING COX PROPORTIONAL HAZARDS MODEL. RESULTS: TWO HUNDRED AND TWELVE CONSECUTIVE PATIENTS AT A SINGLE ACADEMIC INSTITUTION UNDERWENT EVAR FOR INFRARENAL ANEURYSMS. ESTIMATED FREEDOM FROM PROGRESSION TO STAGE 3 CKD WAS 80%, 76%, AND 63% AT 6, 12, AND 18 MONTHS, RESPECTIVELY, AND FOR STAGE 4, 97%, 96%, AND 93% AT 6, 12, AND 18 MONTHS, RESPECTIVELY. STAGE 3 CKD PREDICTORS OF PROGRESSION INCLUDED AGE (ODDS RATIO (OR): 1.106, P=0.001), DIABETES (OR: 3.052, P=0.04), PERIOPERATIVE USE OF ANGIOTENSIN CONVERTING ENZYME INHIBITORS OR ANGIOTENSIN RECEPTOR BLOCKERS (OR: 3.249, P=0.02), AND OPERATIVE BLOOD LOSS (OR: 1.002, P<(><<)>0.01). STAGE 4 PREDICTORS INCLUDED PREOPERATIVE HEMOGLOBIN (OR: 0.473, P=0.04) AND BASELINE RENAL FUNCTION (OR: 0.928, P=0.001). INTRAOPERATIVE CONTRAST ADMINISTRATION DID NOT IMPACT CKD DEVELOPMENT. CONCLUSIONS: PROGRESSION TO STAGE 3 CKD AFTER EVAR OCCURS MORE FREQUENTLY AND AT A HIGHER RATE COMPARED WITH PROGRESSION TO STAGE 4. DIFFERENT RISK FACTORS ARE ASSOCIATED WITH PROGRESSION TO EACH OF THOSE STAGES OF CKD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118716 TALENT AAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other