BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL

    MDR report key: 3071540 · Received April 22, 2013

    Report

    Report Number
    2953200-2013-00750
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    March 28, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK, STENT GRAFT KINK, SURGICAL CONVERSION); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (TYPE II ENDOLEAK). CONCLUSION: KNOWN INHERENT RISK OF A PROCEDURE (ENDOLEAK, STENT GRAFT KINK, SURGICAL CONVERSION); DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (TYPE II ENDOLEAK).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED, MAGNETIC RESONANCE IMAGING IS MORE SENSITIVE THAN COMPUTED TOMOGRAPHY ANGIOGRAPHY FOR THE DETECTION OF ENDOLEAKS AFTER ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR: A SYSTEMATIC REVIEW: 2013 EUROPEAN SOCIETY FOR VASCULAR SURGERY. OBJECTIVES: THE PURPOSE OF THIS SYSTEMATIC REVIEW WAS TO EXAMINE WHETHER MAGNETIC RESONANCE IMAGING (MRI) OR COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IS MORE SENSITIVE FOR THE DETECTION OF ENDOLEAKS IN PATIENTS WITH ABDOMINAL AORTIC ANEURYSM (AAA) AFTER EVAR. MATERIALS AND METHODS: A SYSTEMATIC ELECTRONIC SEARCH WAS PERFORMED. ARTICLES WERE INCLUDED WHEN POST-EVAR PATIENTS WERE EVALUATED BY BOTH MRI AS INDEX TEST AND CTA AS COMPARISON. METHODOLOGICAL QUALITY WAS ASSESSED WITH THE QUALITY ASSESSMENT OF DIAGNOSTIC ACCURACY STUDIES (QUADAS) TOOL. PRIMARY OUTCOME WAS THE PROPORTION OF PATIENTS IN WHOM MRI DETECTED ADDITIONAL ENDOLEAKS, WHICH WERE NOT SEEN WITH CTA. RESULTS: ELEVEN ARTICLES WERE INCLUDED. THE OVERALL METHODOLOGICAL QUALITY OF THE ARTICLES WAS GOOD. IN TOTAL, 369 PATIENTS WITH 562 MRI AND 562 CTA EXAMINATIONS WERE INCLUDED. A TOTAL OF 146 ENDOLEAKS WERE DETECTED BY CTA; MRI DETECTED ALL BUT TWO OF THESE ENDOLEAKS. WITH MRI 132 ADDITIONAL ENDOLEAKS WERE FOUND. CONCLUSIONS: MRI IS MORE SENSITIVE COMPARED TO CTA FOR THE DETECTION OF POST-EVAR ENDOLEAKS, ESPECIALLY FOR THE DETECTION OF TYPE II ENDOLEAKS. MRI SHOULD BE CONSIDERED IN PATIENTS WITH CONTINUED AAA GROWTH AND NEGATIVE OR UNCERTAIN FINDINGS AT CTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171240 TALENT ABDOMINAL SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention