BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3211793 · Received July 8, 2013

    Report

    Report Number
    2953200-2013-01276
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    June 11, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK, INFECTION); LACK OF INFORMATION (CAUSE IS UNKNOWN). CONCLUSION: LACK OF INFORMATION (CAUSE IS UNKNOWN).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: CHALLENGING TREATMENT OF MULTIPLE LATE COMPLICATIONS AFTER ENDOVASCULAR ANEURYSM REPAIR, DAMIR VAKHITOV. ANN VASC SURG 2012; 26: 572.E1E572.E3 DOI: 10.1016/J.AVSG.2011.09.006 ON AN UNKNOWN DATE BETWEEN 2005 AND 2009, AN UNKNOWN ENDURANT STENT GRAFT CUFF WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6CM INFRARENAL ABODOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT AFTER THE INTERVENTION THE PATIENT PRESENTED GENERALIZED TUBERCULOSIS (TBC). TWICE-PERFORMED POSITRON EMISSION TOMOGRAPHY SCANS ALSO SHOWED POSSIBLE PROSTHESIS INFECTION, IN ADDITION TO THE PROBLEM THAT NEITHER ENDOTENSION NOR THE ENDOLEAK HAD RESOLVED. THE PATIENT WAS ADMINISTERED A LONG-TERM ANTIBIOTIC TREATMENT. AT THE SAME TIME, ENDOLEAKS WERE TREATED AGAIN ENDOVASCULARLY. BACKGROUND: TO REPORT A CASE OF MULTIPLE ADDITIONAL PROCEDURES AFTER SUCCESSFUL ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSM. METHODS: AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR WITH A BIFURCATED AORTIC VANGUARD ENDOGRAFT SUCCESSFULLY PERFORMED IN 1999 RESULTED IN MULTIPLE COMPLICATIONS, INCLUDING ENDOLEAKS AND A ROW SEPARATION, TREATED ENDOVASCULARLY. SUBSEQUENTLY, TUBERCULOSIS SEPSIS AND PROSTHESIS INFECTION RESULTED IN LONG-TERM ANTIBIOTIC TREATMENT. ADDITIONAL GRAFT LEAKS, ANEURYSM SACK GROWTH, AND SACK RUPTURES WERE ALSO TREATED ENDOVASCULARLY BECAUSE THE PATIENT CONSISTENTLY DENIED OPEN REPAIR. ENDOVASCULAR PROCEDURES, HOWEVER, DID NOT SOLVE THE PROBLEM ,TURNING TO BE INCREASINGLY CHALLENGING. THE PATIENT FINALLY APPROVED OPEN GRAFT REMOVAL AND AORTOBIFEMORAL RECONSTRUCTION THAT WERESUCCESSFULLY PERFORMED 11 YEARS AFTER THE INITIAL ENDOGRAFT IMPLANTATION. RESULTS: THE PATIENT HAS RECOVERED FROM SURGERY WELL AND IS ASYMPTOMATIC. NO EVIDENCE OF BACTERIAL COLONIZATION WAS FOUND ACCORDING TO THE SPECIMEN TAKEN DURING THE LAPAROTOMY. CONCLUSION: VANGUARD AND OTHER FIRST-GENERATION AORTIC ENDOGRAFTS ARE ASSOCIATED WITH HIGH INCIDENCE OF COMPLICATIONS AND RE-INTERVENTIONS. OPEN SURGERY IS A METHOD OF CHOICE IN SIMILAR CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309904 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention