BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT STENT GRAFT SYSTEM

    MDR report key: 2861363 · Received December 7, 2012

    Report

    Report Number
    2953200-2012-02363
    Event Type
    Death
    Date Received
    December 7, 2012
    Report Date
    November 9, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (MIGRATION, KINK, ENDOLEAK, RENAL ISSUES, DEATH), (UNKNOWN CAUSE OF EVENT). CONCLUSION: (UNKNOWN CAUSE OF EVENT).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE WHICH IS SUMMARIZED AS FOLLOWS: EVIDENCE FOR ENDOVASCULAR ANEURYSM REPAIR IN PATIENTS WITH HIGHLY ANGULATED NECK ANATOMY. JOURNAL OF CARDIOVASCULAR SURGERY VOL.53 (4) P433-45 AUG 2012. PATIENTS WITH HIGHLY ANGULATED NECK ANATOMY MAY ACCOUNT FOR UP TO A FIFTH OF ALL PATIENTS TREATED BY ENDOVASCULAR REPAIR. HOWEVER THERE IS EVIDENCE THAT THESE PATIENTS HAVE WORSE EARLY AND LONG-TERM OUT COMES, INCLUDING SAC EXPANSION. THIS REVIEW EXPLORES THE EVIDENCE SUPPORTING THE USE OF ENDOVASCULAR REPAIR IN THE SETTING OF SEVERE NECK ANGULATION, WITH PARTICULAR EMPHASIS ON NEW TECHNOLOGY WITH DEVICES THAT HAVE EXPANDED THE ANATOMICAL CRITERIA FOR ENDOVASCULAR ANEURYSM REPAIR SUCH AS THE LOMBARD AORFIX AND MEDTRONIC ENDURANT ENDOGRAFTS. THERE IS INCREASING EVIDENCE THAT THE OUTCOME OF ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSM (EVAR) IS INFLUENCED BY ANATOMICAL FACTORS. INDEED, EVERY STENT GRAFT HAS INSTRUCTIONS FOR USE WITHIN WHICH ARE ANATOMICAL SELECTION CRITERIA. HOWEVER IT IS "DEAR" THAT PATIENTS WITH ANATOMY OUTSIDE THE RECOMMENDED LIMITS ARE BEING TREATED BY EVAR. THE (B)(4) REGISTRY DATA SHOWED THAT OVER 20% OF PATIENTS WITH NECK ANGULATION OF >60 DEGREES WERE TREATED BETWEEN 1996 AND 2006. PATIENTS WITH SEVERE NECK ANGULATION WERE TWICE AS LIKELY TO SUFFER AN EARLY (<(> <<)>(> <(><<)><(><<)>)>30 DAYS) OR LATE (>30 DAYS) TYPE I ENDOLEAK AND WERE ALSO SIGNIFICANTLY MORE LIKELY TO UNDERGO SECONDARY INTERVENTION. IN ADDITION THERE WAS AN INCREASED RISK OF LATE RUPTURE OR ANEURYSM RELATED MORTALITY. (B)(6) ANALYZED (B)(4) EVARS OVER A SIMILAR TIME PERIOD AND FOUND THAT APPLICATION OF THE COOK ZENITH, GORE EXCLUDER AND MEDTRONIC ANEURX GRAFTS OUTSIDE THE ANATOMICAL CRITERIA WAS ASSOCIATED WITH INCREASING RISK OF GRAFT RELATED ADVERSE EVENTS BUT HAD NO INFLUENCE ON AAA RELATED DEATH. THE AUSTRALIAN ENDOVASCULAR RISK ASSESSMENT (ERA), BASED ON AN ASSESSMENT OF (B)(4) EVARS, INCLUDES THREE ANATOMICAL CRITERIA TO ESTIMATE PREDICTED SUCCESS: AORTIC NECK ANGLE, INFRARENAL NECK DIAMETER AND INFRARENAL NECK LENGTH. AN INFRARENAL NECK ANGLE OF >45 DEGREES WAS THE ONLY ANATOMICAL VARIABLE STATISTICALLY ASSOCIATED WITH TECHNICAL AND CLINICAL SUCCESS. MOST RECENTLY (B)(6) HAVE REPORTED THAT SAC ENLARGEMENT IS SIGNIFICANTLY INFLUENCED BY AORTIC NECK DIAMETER (>28 MM); AORTIC NECK ANGLE (>60 DEGREES) AND COMMON ILIAC ARTERY DIAMETER (>20 MM). THE AUTHORS SUGGEST THAT ANATOMICAL CRITERIA HAVE BECOME TOO LIBERAL OVER TIME, AND THAT THIS HAS BEEN REFLECTED IN WORSENING OUTCOMES. NEVERTHELESS MORE PATIENTS THAN EVER ARE CHOOSING ENDOVASCULAR REPAIR. IS IT SAFE TO CONTINUE OFFERING THIS TREATMENT TO PATIENTS WITH HIGHLY ANGULATED NECK ANATOMY. DEFINITIONS OF ANATOMY: REPORTING STANDARDS FOR OUTCOMES FOLLOWING ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSMS WERE PUBLISHED IN 2002. AT THE SAME TIME THE SOCIETY FOR VASCULAR SURGERY/INTERNATIONAL SOCIETY FOR CARDIOVASCULAR SURGERY PUBLISHED GUIDELINES ON IDENTIFICATION AND GRADING OF FACTORS THAT MODIFY THE OUTCOME OF EVAR. MORE RECENTLY, IN RESPONSE TO POOR COMPLIANCE WITH THE AMERICAN GUIDANCE AND THE EVOLUTION OF ENDOVASCULAR TREATMENT WITH BRANCHED AND FENESTRATED REPAIR, THE BRITISH SOCIETY OF ENDOVASCULAR SURGERY HAS PROPOSED MORE PRAGMATIC MINIMUM REPORTING STANDARDS. NECK ANGULATION: THERE ARE TWO IMPORTANT ANGLES THAT SHOULD BE CONSIDERED FOR INFRA-RENAL GRAFTS. THE FIRST, IS THE MAXIMUM ANGLE, IN ANY PLANE, BETWEEN THE SUPRA-RENAL AORTA AND THE AORTIC ANEURYSM NECK (A ANGLE). THE SECOND ANGLE IS THE MAXIMUM ANGLE BETWEEN THE NECK AND THE ANEURYSM (B ANGLE). THE B ANGLE IS THE ANGLE TYPICALLY REFERRED TO WHEN STUDIES CONSIDER ANEURYSM NECK ANGULATION. IT IS RECOMMENDED THE ANGLES SHOULD BE MEASURED ALONG THE CENTRELINE OF THE VESSELS. DESPITE THE IMPORTANCE OF THESE ANGLES IN THE MANUFACTURER'S INSTRUCTIONS FOR USE AND THE PRESENCE WITHIN THE REPORTING GUIDANCE, THERE IS LITTLE IN THE LITERATURE TO DESCRIBE EXACTLY HOW THE ANGLES SHOULD BE MEASURED. FURTHERMORE, IT IS KNOWN THERE IS WIDESPREAD INTER OBSERVATION VARIATION - MEASUREMENTS MAY VARY BY UP TO 30%. (B)(6) HAS DESCRIBED A STANDARDIZED METHOD OF MEASURING NECK ANGULATION, BUT THIS HAS NOT BEEN WIDELY ADOPTED. GRAFT SPECIFIC OUTCOMES EVERY GRAFT ON THE MARKET HAS PUBLISHED INSTRUCTIONS FOR USE; TABLE II SUMMARISES THE VARIOUS ANATOMICAL LIMITATIONS RELATING TO NECK ANGULATION AND LENGTH IN THE INSTRUCTIONS FOR USE OF INTRA-RENAL GRAFTS THAT ARE CURRENTLY AVAILABLE AND COMMONLY USED. THERE IS A GROWING BODY OF EVIDENCE THAT THESE GRAFTS CAN BE APPLIED TO PATIENTS WITH HIGHLY ANGULATED ANATOMY WITH VARIABLE SUCCESS - THIS IS SUMMARISED IN TABLE III. GIVEN THE OVERLAP BETWEEN CASES SERIES IN THE STUDIES META-ANALYSIS OF THESE DATA WAS NOT PERFORMED. EARLY REPORTS OF DEVICES WHICH HAVE NOW BEEN SUPERSEDED, SUCH AS THE GUIDANT ANCURE, MEDTRONIC ANEURX AND TALENT GRAFT SUGGEST THAT HOSTILE NECK ANATOMY, IN PARTICULAR NECK ANGULATION WAS ASSOCIATED WITH POOR OUTCOMES IN EARLY AND MID-TERM FOLLOW-UP. NECK ANGULATION APPEARED TO AFFECT OUTCOMES AS IT INCREASED OVER 45 DEGREES WHICH IS IN KEEPING WITH THE AUSTRALIAN SERIES. SIGNIFICANT KINKING WAS SEEN WITH THE TALENT GRAFT AS HIGHER NECK ANGLES. IN THE LAST FIVE YEARS A NUMBER OF NEWER GRAFTS HAVE BEEN APPLIED TO HIGH ANGLED NECKS. THE DATA IN TABLE III SUGGESTS THAT HIGH DEGREES OF TECHNICAL SUCCESS CAN BE ACHIEVED, ALTHOUGH IT IS NOT UNCOMMON TO APPLY AN INTRAOPERATIVE ADJUNCT. IN THE MOST RECENT SERIES NECK ANGULATION HAS NOT BEEN STATISTICALLY ASSOCIATED WITH WORSE OUTCOME. EARLY CLINICAL SUCCESS VARIES FROM 90-100% AND THOSE SERIES REPORTING BEYOND A YEAR HAVE RE-INTERVENTION RATES OF 5-10% AT ONE YEAR. THIS LEVEL OF RE-INTERVENTION IS IN KEEPING WITH THAT OBSERVED IN A RECENT LARGE COHORT SERIES OF PATIENTS TREATED WITH EVAR. CONCLUSION: CLINICIANS SHOULD BE AWARE THAT THE STUDY SUGGESTING THAT ENDOVASCULAR ANEURYSM REPAIR IN PATIENTS WITH HIGH NECK ANGULATION RESULTS IN A HIGH RISK OF SAC EXPANSION HAS SOME MAJOR METHODOLOGICAL WEAKNESSES, WHICH UNDERMINE THE EXTERNAL VALIDITY OF THE FINDINGS. IT IS, HOWEVER, CLEAR FROM MANY STUDIES THAT INTRAOPERATIVE ADJUNCTS ARE OFTEN REQUIRED TO ACHIEVE TECHNICAL AND CLINICAL SUCCESS. EARLY AND SHORT-TERM CLINICAL SUCCESS OF GRAFTS DESIGNED TO TREAT PATIENTS WITH CHALLENGING ANGULATED ANATOMY (LOMBARD AORFIX AND MEDTRONIC ENDURANT) ARE ENCOURAGING AND SUGGEST THAT IT IS SAFE TO TREAT PATIENTS WITHIN THE MANUFACTURERS ANATOMICAL SELECTION CRITERIA. DATE OF DEATH IS UNKNOWN

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R