BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3020028 · Received March 25, 2013

    Report

    Report Number
    2953200-2013-00522
    Event Type
    Injury
    Date Received
    March 25, 2013
    Date of Event
    October 26, 2013
    Report Date
    December 12, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: FILM.

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS, CONCLUSIONS: ENDOLEAK, REMOVAL OF IMPLANT. UNKNOWN CAUSE OF EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: (FILMS). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANGULATED AORTIC NECK). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANGULATED AORTIC NECK).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURE. A CT SCAN REVEALED THAT THE ANEURX BIFURCATE STENT GRAFT FELL INTO THE ANEURYSM SAC, SEPARATING FROM THE LOWEST PROXIMAL ENDURANT EXTENSION STENT GRAFT, CAUSING A TYPE III ENDOLEAK. THE PATIENT WAS CONVERTED TO OPEN REPAIR AND IS DOING WELL.

    Description of Event or Problem · 1

    FILM REVIEW ANALYSIS: POST-IMPLANT IMAGES SHOWED THAT THE ENDURANT CUFFS HAD BEEN IMPLANTED BETWEEN THE ANEURX BIFURCATE AND RENALS. THERE DOES NOT APPEAR TO BE ANY COMPONENT SEPARATION OR ENDOLEAK, HOWEVER, ONLY THE SAGITTAL IMAGES WERE RETURNED FOR VIEWING. BOTH LIMBS ARE PATENT. THE ANEURX IS APPROXIMATELY 7CM BELOW THE RENALS. THE IMAGES PROVIDED TO NOT APPEAR TO SHOW THE REPORTED TYPE III SEPARATION ENDOLEAK EVENT.

    Description of Event or Problem · 1

    AN ANEURX ABDOMINAL STENT GRAFT LIMB WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 67 MONTHS AGO. ANEURYSM MORPHOLOGY AT THE TIME OF IMPLANT IS UNKNOWN. IT WAS REPORTED THAT IT WAS REPORTED THAT THE PATIENT WAS SYMPTOMATIC AND PRESENTED TO THE ER. A CT SCAN REVEALED THAT A PIECE OF THE BIFURCATED STENT GRAFT HAD TORN OFF FROM THE PROXIMAL EDGE AND WAS FLOATING IN THE ANEURYSM. THE CAUSE OF THE TEAR IS UNKNOWN. THERE WAS A LARGE ENDOLEAK WITH SIGNIFICANT ANEURYSM ENLARGEMENT. THE PHYSICIAN IMPLANTED TWO ENDURANT CUFFS A 363670 AND A 363649 AND THIS SUCCESSFULLY RESOLVED THE ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. REVIEW OF RETURNED FILMS POST IMPLANT SHOW THAT THE STENT GRAFT IS 4-5CM BELOW THE RENALS. THE IPSILATERAL LIMB IS IN THE LEFT ILIAC; CROSSING OVER THE CONTRALATERAL LIMB. THERE IS A PROXIMAL TYPE I ENDOLEAK. NO OTHER ENDOLEAK IS IDENTIFIED. THE NECK IS ANGULATED APPROXIMATELY 70DEG LT-RT. THE MAX AAA DIAMETER IS 7CM. THERE APPEARS TO BE GOOD DISTAL SEALING BILATERALLY. A SINGLE RING SECTION OF THE STRUT (APPROXIMATELY 2.5CM LONG X 1CM TALL) WAS OBSERVED SEPARATED FROM THE STENT GRAFT AND IS LOCATED NEAR THE RIGHT/TOP WALL OF THE SAC. FROM 3D RECONSTRUCTION, THE SEVERED STRUT MAY HAVE BROKEN AWAY FROM THE MID-LENGTH OF THE IPSILATERAL LIMB, WHICH CURRENTLY SHOWS A "MISSING" SECTION OF STRUTS APPROXIMATELY THE SAME SIZE AS THE SEVERED STRUT. THE CAUSE OF THE STENT FRACTURE AND SEVERANCE IS UNCERTAIN. IMAGES AT IMPLANT AND EARLIER FOLLOW-UP WERE NOT PROVIDED. THE CAUSE OF THE MIGRATION IS ALSO UNKNOWN; THE ANGULATED NECK MAY HAVE CONTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121959 ANEURX ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00028263

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention