BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AAA STENT GRAFT

    MDR report key: 6501043 · Received April 18, 2017

    Report

    Report Number
    2953200-2017-00627
    Event Type
    Injury
    Date Received
    April 18, 2017
    Date of Event
    August 1, 2010
    Report Date
    March 28, 2017
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    (B)(4). 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

    THE PREVIOUS CORRECTIVE MDR WAS SENT IN ERROR. THE ACTUAL CORRECTED INFORMATION IS AS FOLLOWS: CORRECTION: FDD CODE (B)(4) WAS CODED INCORRECTLY AND HAS BEEN REMOVED.

    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: DEVICE-SPECIFIC OUTCOMES AFTER ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR. BASTOS GONCALVES F1, ROUWET ELLEN V, METZ R, HENDRIKS JM, VRANCKEN PEETERS M-, MUHS BE, VERHAGEN HJ. J CARDIOVASC SURG (TORINO). 2010 AUG;51(4):515-31. AN ANEURX, TALENT AND ENDURANT STENT GRAFT SYSTEMS WERE IMPLANTED IN THE PATIENT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND RUPTURED AORTIC ANEURYSMS. THE FOLLOWING INFORMATION IS IN THIS JOURNAL ARTICLE: (ANEURX) MIGRATION, TYPE I ENDOLEAK, POST-OPERATIVE RUPTURE, STENT FRACTURE, STENT SEVERANCE, CONNECTING BAR FRACTURE. (TALENT) MIGRATION, TYPE I ENDOLEAK, STENT FRACTURE, CONNECTING BAR FRACTURE, POST-OPERATIVE RUPTURE ANEURYSM, VESSEL OCCLUSION, STENT SEVERANCE, LIMB OCCLUSION. (ENDURANT) TYPE I ENDOLEAK, LIMB OCCLUSION, FEMORAL PSEUDO-ANEURYSM. ABSTRACT OVER THE LAST DECADE, ENDOVASCULAR ANEURYSM REPAIR (EVAR) HAS BEEN USED EXTENSIVELY FOR THE ELECTIVE TREATMENT OF INFRA-RENAL ABDOMINAL ANEURYSMS. HOWEVER, IT REMAINS UNCLEAR HOW SPECIFIC DEVICES PERFORM AND HOW THEY COMPARE TO OTHERS. WE PROVIDE AN OVERVIEW OF CURRENTLY USED ENDOGRAFTS, AND DISCUSS THE CURRENT EVIDENCE REGARDING DEVICE-SPECIFIC OUTCOMES. PUBLISHED LITERATURE CONFIRMS DIFFERENCES IN RESULTS ACCORDING TO ENDOGRAFT SELECTION. THESE DIFFERENCES WERE MORE PRONOUNCED WITH OLDER GENERATIONS OF DEVICES, IN COMPARISON TO NEWER MODELS. CONTEMPORARY RESULTS ARE GENERALLY GOOD AND ONE SHOULD REMEMBER THAT NO RANDOMIZED DATA EXIST REGARDING INDIVIDUAL DEVICE PERFORMANCE. MOREOVER, BY THE TIME THERE IS ENOUGH FOLLOW-UP TO DRAW CONCLUSIONS, THE DATA IS RELATIVELY OBSOLETE DUE TO CONSTANT IMPROVEMENTS IN ENDOGRAFT TECHNOLOGY AND DESIGN. RESULTS FROM EVAR HAVE BEEN STEADILY IMPROVING AND INDIVIDUALIZED DEVICE SELECTION HAS SHOWN TO BE VALUABLE. IT APPEARS THAT PATIENTS WITH FAVORABLE ANATOMY DO WELL WITH MOST MODERN ENDOGRAFTS. THOSE WITH CHALLENGING ANATOMIES MAY BENEFIT MORE FROM A PARTICULAR DESIGN, DELIVERY AND DEPLOYMENT FEATURE REQUIRING GREATER KNOWLEDGE AND EXPERIENCE FOR ADEQUATE DEVICE SELECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282945 TALENT AAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention