BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 6501065 · Received April 18, 2017

    Report

    Report Number
    2953200-2017-00628
    Event Type
    Injury
    Date Received
    April 18, 2017
    Date of Event
    August 1, 2010
    Report Date
    March 28, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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

    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: 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
    281074 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention