BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 5498461 · Received March 14, 2016

    Report

    Report Number
    2953200-2016-00461
    Event Type
    Injury
    Date Received
    March 14, 2016
    Date of Event
    January 13, 2015
    Report Date
    February 19, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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; ANALYSIS OF ANATOMICAL RISK FACTORS FOR PERSISTENT TYPE II ENDOLEAKS FOLLOWING ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR USING CT ANGIOGRAPHY. MASAYOSHI OTSU · TORU ISHIZAKA · MICHIKO WATANABE · TAKAKI HORI · HIROKI KOHNO · KEIICHI ISHIDA · MITSURU NAKAYA · GORO MATSUMIYA. DOI 10.1007/S00595-015-1115-5. SURG TODAY (2016) 46:48¿55 AN ENDURANT STENT GRAFT SYSTEMS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AND/OR AORTOILIAC ARTERY ANEURYSM. THE FOLLOWING INFORMATION IS REVIEWED IN THIS JOURNAL ARTICLE: TYPE IB ENDOLEAK, TYPE III ENDOLEAK AND TYPE II ENDOLEAKS. ABSTRACT: PURPOSE TO PREDICT PERSISTENT TYPE II ENDOLEAKS (PT2ES) FOLLOWING ENDOVASCULAR ANEURYSM REPAIR (EVAR) OF ABDOMINAL AORTIC ANEURYSMS, WE EXAMINED FACTORS RELATED TO POST-EVAR PT2ES. METHODS EIGHTY-FOUR CASES OF EVAR WERE ANALYZED. T2ES THAT PERSISTED FOR =6 MONTHS WERE DEFINED AS PT2ES. PT2ES FLOWING FROM AN INFERIOR MESENTERIC ARTERY (IMA) AND LUMBAR ARTERY (LA) WERE TERMED PIMA-T2ES AND PLAT2ES, RESPECTIVELY. THE ANATOMICAL FACTORS CONCERNING THE ANEURYSM, IMA AND LAS WERE ASSESSED IN THE PREOPERATIVE CT ANGIOGRAPHY IMAGES. A STATISTICAL ANALYSIS WAS PERFORMED ON THE FACTORS ASSOCIATED WITH PT2ES. RESULTS THE INCIDENCE OF PT2ES WAS 25 %. PT2ES WERE ASSOCIATED WITH POSTOPERATIVE CHANGES IN THE ANEURYSM DIAMETER. A UNIVARIATE ANALYSIS SHOWED THAT A SAC THROMBUS AND THE NUMBER OF PATENT SIDE BRANCHES ARISING FROM AN ANEURYSM WERE SIGNIFICANT FACTORS ASSOCIATED WITH PT2ES. THE IMA DIAMETERS WERE SIGNIFICANTLY LARGER IN CASES OF PIMA-T2ES. THE SIGNIFICANT FACTORS ASSOCIATED WITH PLAT2ES WEREA CIRCUMFERENTIAL THROMBUS, THE NUMBER OF PATENT LAS AND THE MEAN LA DIAMETER. MULTIVARIATE ANALYSES INDICATED THAT A CIRCUMFERENTIAL THROMBUS WAS A PROTECTIVE FACTOR FOR PT2ES, WHEREAS AN IMA =2.6 MM AND EACH ADDITIONAL LA BRANCH =1.9 MM WERE POWERFUL RISK FACTORS FOR A PT2E. CONCLUSION SIGNIFICANT ANATOMICAL FACT ORS ASSOCIATED WITH PT2E WERE FOUND IN THIS STUDY. THESE FACTORS MAY BE USEFUL IN SELECTING PATIENTS FOR PERIOPERATIVE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153604 ENDURANT STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Required Intervention