BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 3150678 · Received June 6, 2013

    Report

    Report Number
    2953200-2013-01076
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    January 1, 2009
    Report Date
    May 16, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ENDOLEAK. 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 ENTITLED, EVENT RECEIVED FROM A JOURNAL ARTICLE; HYBRID ENDOGRAFTS COMBINATIONS FOR THE TREATMENT OF ENDOLEAK IN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR, G. GEORGIADIS, INT J ARTIF ORGANS 2013; 36 (1):28-38 DURING THE STUDY OF HYBRID ENDOGRAFTS A PATIENT WAS TREATED FOR A TALENT TYPE 1B DISTAL ENDOLEAK AND TYPE III ENDOLEAK THAT WAS RELINED USING ENDURANT LIMB STENT GRAFTS. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. HYBRID ENDOGRAFTING IN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR) IS DEFINED AS THE PROCESS OF PLACING A SERIES OF TWO OR MORE DIFFERENT TYPES OF COVERED STENTS, USUALLY TO TREAT A COMPLEX ABDOMINAL AORTIC ANEURYSM (AAA) OR A PRIMARY OR SECONDARY ENDOLEAK. WE DESCRIBE THE TREATMENT OF A TYPE III, A TYPE IB, AND A TYPE IA ENDOLEAK IN THREE PATIENTS RESPECTIVELY, USING HYBRID SOLUTIONS, ASSEMBLING COMPONENTS FROM DIFFERENT MANUFACTURERS. AN UPDATE OF THE CURRENT CLINICAL AND EXPERIMENTAL EVIDENCE ON THE APPLICATION OF ANATOMICALLY COMPATIBLE, HYBRID ENDOGRAFT SYSTEMS IN CONVENTIONAL EVAR IS ALSO PROVIDED. MANY INCIDENCES OF MIXING AND MATCHING DIFFERENT COMPONENTS IN EVAR HAD BEEN PERFORMED SINCE THE EARLY INTRODUCTION OF THE ANEURX (MEDTRONIC) DEVICE, FROM THE EARLY EMPLOYMENT OF TALENT (MEDTRONIC) PROXIMAL EXTENSION CUFFS WITH SUPRARENAL FIXATION TO BELLBOTTOM CONFIGURATIONS. THERE IS EVEN A COMMERCIAL PRODUCT (ZENITH RENU; (B)(4)) DESIGNED TO BE USED TO TREAT DISTAL MIGRATION OF OLDER GENERATION (ANEURX; MEDTRONIC) ENDOGRAFTS WITHOUT SUPRARENAL FIXATION. THUS, HYBRID TECHNIQUES ARE NECESSARILY PERFORMED ON SOME OCCASIONS AND THE EXACT PERCENTAGE IS LIKELY TO BE UNDERESTIMATED. EXACT DATE OF EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250798 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1