BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 3150681 · Received June 6, 2013

    Report

    Report Number
    2953200-2013-01077
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    November 11, 2007
    Report Date
    August 1, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ENDOLEAK, ANEURYSM RUPTURE, SURGICAL CONVERSION TO OPEN REPAIR. CAUSE OF EVENT IS UNKNOWN. CONCLUSIONS: CAUSE OF EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A LEAKING AORTIC ANEURYSM OVER SIX YEARS AGO. APPROXIMATELY FOUR YEARS AFTER THE ANEURX DEVICES WERE IMPLANTED THE PATIENT RECEIVED A SECONDARY PROCEDURE WITH A TALENT STENT GRAFT DUE TO AN UNKNOWN ENDOLEAK. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH BACK PAIN AND A CT SCAN REVEALED THE PRESENCE OF AN ACTIVE CONTROLLED RUPTURE. THE PATIENT WAS CONVERTED TO OPEN SURGICAL REPAIR AND THE CASE WAS COMPLETED SUCCESSFULLY. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS DOING FINE.

    Description of Event or Problem · 1

    EXAMINATION OF THE RETURNED DEVICES COULD NOT CONFIRM THE CAUSE OF THE ANEURYSM EXPANSION AND RUPTURE. THE CAUSE OF THE EARLIER REPORTED UNKNOWN ENDOLEAK ALSO COULD NOT BE DETERMINED. NO STENT GRAFT INTEGRITY ISSUES WERE OBSERVED ALONG THE PROXIMAL SEALING ZONE OF THE BIFURCATE (RINGS 1 ¿ 2). OTHER THAN A SINGLE STENT FRACTURE SEEN ON THE AORTIC BODY AT RING 4 AND SEVERAL BROKEN SUTURES, NO OTHER DEVICE INTEGRITY ISSUES WERE OBSERVED WITH THE BIFURCATE. AN ANEURX AORTIC CUFF WAS FOUND PLACED WITHIN THE AORTIC BODY, EXTENDING 5 MM ABOVE THE BIFURCATE. ANOTHER MANUFACTURER STENT, WHICH APPEARED TO HAVE BEEN IMPLANTED WITHIN THE AORTIC BODY, WAS ALSO RETURNED DETACHED FROM THE DEVICES. NO DEVICE INTEGRITY ISSUES WERE SEEN WITH THE AORTIC CUFF, CONTRALATERAL LIMB OR IPSILATERAL EXTENSION. THE CONTRALATERAL EXTENSION WAS FOUND TO HAVE MULTIPLE ABRASION RELATED FABRIC HOLES, WITH ASSOCIATED STENT FRACTURES AND SUTURE BREAKS, NEAR THE ANGULATED DISTAL END OF THE LIMB. THE CAUSE OF THESE FINDINGS WAS LIKELY DUE TO PLACEMENT OF THIS LIMB IN A HIGHLY ANGULATED ILIAC ANATOMY. IT IS POSSIBLE THAT THESE HOLES MAY HAVE CONTRIBUTED TO THE RUPTURE; HOWEVER, THE HOLES APPEARED ¿COVERED¿ BY TISSUE/THROMBUS IN THE RETURNED CONDITION, AND THEREFORE WERE NOT LIKELY THE SOURCE OF ANY ENDOLEAK.

    Description of Event or Problem · 1

    MFR REPORT NUMBER 2953200-2013-01077- INITIAL; AND MFR REPORT NUMBER 2953200-2013-01077- SUPPLEMENTAL 001 ARE BEING REDACTED. INFORMATION FILED IN ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250799 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA 1000687

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention