BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT AAA

    MDR report key: 3851550 · Received June 5, 2014

    Report

    Report Number
    2953200-2014-01133
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    September 29, 2013
    Report Date
    May 12, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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: SURVEILLANCE COMPUTED TOMOGRAPHIC ARTERIOGRAM DOES NOT CHANGE MANAGEMENT BEFORE 3 YEARS IN PATIENTS WHO HAVE A NORMAL POST-EVAR STUDY. VINCENT E. KIRKPATRICK, SAMUEL E. WILSON, RUSSELL A. WILLIAMS, AND IAN L. GORDON. ANN VASC SURG 2014; 28: 831¿836 EITHER A TALENT AND ANEURX STENT GRAFT SYSTEMS WERE USED FOR THE TREATMENT OF ABDOMINAL AORTIC ANEURYSMS. THE TYPE I ENDOLEAK WAS DE TECTED 3.5 YEARS AFTER EVAR AND WAS ASSOCIATED WITH ANEURYSM SAC EXPANSION OF 1.2 MM COMPARED WITH THE PATIENT¿S 1-MONTH CTA. THERE IS NO FURTHER INFORMATION AVAILABLE. BACKGROUND: STANDARD SURVEILLANCE AFTER ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR) CONSISTS OF PERIODIC COMPUTED TOMOGRAPHIC ARTERIOGRAPHIES (CTAS) USUALLY PERFORMED AT POSTOPERATIVE MONTHS 1, 6, AND 12, AND THEN ANNUALLY. THIS IMAGING REGIMEN IS EXPENSIVE AND EXPOSES PATIENTS TO THE HAZARDS OF RADIATION AND INTRAVENOUS CONTRAST. WE HYPOTHESIZED THAT A NORMAL 1-MONTH CTA AFTER EVAR WITH NO ENDOLEAK OR OTHER SIGNIFICANT ABNORMALITY PREDICTS A LOW RATE OF FUTURE COMPLICATIONS, WHICH WOULD JUSTIFY A REDUCTION IN FREQUENCY OF SUBSEQUENT CTAS. METHODS: WE IDENTIFIED 106 CONSECUTIVE PATIENTS WHO UNDERWENT EVAR AT A SINGLE HOSPITAL FROM 2003 TO 2010 AND REVIEWED ALL THEIR CTAS. FIFTEEN PATIENTS FOR WHOM WE COULD NOT REVIEW A POSTOPERATIVE CTA WERE EXCLUDED. OF THE REMAINING 91 PATIENTS, 70 (76.9%) HAD NO ABNORMALITY ON THEIR CTA AT 1 MONTH AFTER EVAR. THE MEDICAL RECORDS OF THESE 70 PATIENTS WERE ANALYZED FOR SUBSEQUENT COMPLICATIONS AND INTERVENTIONS RELATED TO EVAR. RESULTS: THE MEAN PATIENT FOLLOW-UP WAS 3.4 ± 2.1 YEARS. FIVE OF THE 70 (7.1%) PATIENTS WITH A NORMAL POST-EVAR CTA DEVELOPED LATE COMPLICATIONS CONSISTING OF 1 TYPE I ENDOLEAK, 3 TYPE II ENDOLEAKS, AND 1 CASE OF ENDOTENSION. ONLY THE TYPE I ENDOLEAK AND ONE OF THE TYPE II ENDOLEAKS MET CRITERIA FOR INTERVENTION, AND IN BOTH CASES, THE ENDOLEAKS WERE DISCOVERED >3 YEARS AFTER EVAR. LOG-RANK TEST SHOWED A STATISTICALLY SIGNIFICANT INCREASED FREEDOM FROM ANEURYSM SAC EXPANSION IN PATIENTS WITH A NORMAL COMPARED WITH AN ABNORMAL 1-MONTH CTA (P <(><<)> 0.001). CONCLUSIONS: FOR PATIENTS WHO HAVE A NORMAL CTA WITH NO ENDOLEAK 1 MONTH AFTER EVAR, IT IS REASONABLE TO CONSIDER LESS-FREQUENT CTA SURVEILLANCE BECAUSE NO SIGNIFICANT COMPLICATIONS REQUIRING INTERVENTION OCCURRED BEFORE 3 YEARS. THIS WOULD DECREASE UNNECESSARY CTAS AND HEALTH CARE EXPENDITURES AS WELL AS MINIMIZE PATIENT EXPOSURE TO RADIATION AND INTRAVENOUS CONTRAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328681 TALENT AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR