BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT

    MDR report key: 2063845 · Received April 15, 2011

    Report

    Report Number
    2953200-2011-00820
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: STENT GRAFT MIGRATION, ENDOLEAK. UNKNOWN CAUSE OF STENT GRAFT MIGRATION. CONCLUSION: UNKNOWN CAUSE OF STENT GRAFT MIGRATION.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 85 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT ARE UNKNOWN. IT WAS REPORTED THAT AT A ROUTINE FOLLOW UP VISIT THE STENT GRAFT WAS FOUND TO HAVE MIGRATED DISTALLY 3-4 CM RESULTING IN A PROXIMAL TYPE I ENDOLEAK. THE DECISION WAS MADE TO BRING THE PATIENT BACK AT A LATER DATE FOR IMPLANT OF AN AORTIC CUFF. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA NA 38367

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention