BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2984019 · Received February 28, 2013

    Report

    Report Number
    2953200-2013-00359
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: (FILM). RESULTS: INHERENT RISK OF PROCEDURE (STENT GRAFT MIGRATION, STENT FRACTURE); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DISEASE PROGRESSION, AORTIC NECK DILATATION AND ANGULATION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (DISEASE PROGRESSION, AORTIC NECK DILATATION AND ANGULATION).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT'S AORTIC NECK MEASURED LESS THAN 10 MM IN LENGTH AND THE OTHER SIDE DID NOT HAVE VERY MUCH PURCHASE. THEREFORE THE PHYSICIAN ELECTED TO COMPROMISE THE RENAL ARTERY. TWO ENDURANT AORTIC CUFFS WERE IMPLANTED AND THERE WAS 50% ENCROACHMENT ON THE LEFT RENAL ARTERY; HOWEVER, THERE WAS GOOD BLOOD FLOW THROUGH THE RENAL ARTERY UPON COMPLETION OF THE PROCEDURE. THE PROXIMAL TYPE I ENDOLEAK WAS SUCCESSFULLY RESOLVED.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 56 MM DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY FOUR YEARS AGO. THE AORTIC NECK WAS 27-28 MM IN DIAMETER AND DESCRIBED AS SHORT AND ANGULATED AT THE TIME OF IMPLANT. CURRENTLY THE AORTIC NECK DIAMETER IS 32-33MM, AND THE FEMORAL ARTERIES ARE 7.5MM IN DIAMETER BILATERALLY. IT WAS REPORTED THAT THE TALENT BIFURCATED STENT GRAFT HAD MIGRATED APPROXIMATELY 4 CM. THE MIGRATION WAS ALSO NOTED TWO YEARS AND ONE YEAR AGO. THE RADIOLOGIST NOTED NO EVIDENCE OF AN ENDOLEAK AND THE GRAFT IS IN THE ANEURYSM SURROUNDED BY THROMBUS. INTERVENTION HAS NOT BEEN PERFORMED AND THE PATIENT WILL BE MONITORED BY THE PHYSICIAN. NO FURTHER INFORMATION WAS PROVIDED. REVIEW OF RETURNED FILMS POST-IMPLANT SHOWED THAT THE BIFURCATED STENT GRAFT WAS 4-5CM BELOW THE RENAL ARTERIES IN THE ANEURYSM SAC. THE IPSILATERAL LIMB WAS ON THE LEFT SIDE; AN ANEURX LIMB EXTENDED INTO THE LEFT EXTERNAL ILIAC. THE ANEURX CONTRALATERAL AND CONTRALATERAL EXTENSION WERE PLACED ON THE RIGHT SIDE. THE CONTRAST APPEARED TO BE CONTAINED WITHIN THE THROMBUS; HOWEVER, IT IS UNKNOWN IF THE SAC MAY STILL BE PRESSURIZED. THE AAA DIAMETER MEASURED 6-7CM. THE PROXIMAL NECK DIAMETER AT THE RENAL ARTERIES MEASURED 28 X 34MM AND THE AORTIC NECK WAS ANGULATED 70DEG L-R AND A-P. EARLIER FOLLOW-UP IMAGES WERE NOT PROVIDED. THE CAUSE OF THE MIGRATION APPEARS TO BE DISEASE PROGRESSION WITH NECK DILATATION AND ANGULATED NECK. ALSO OBSERVED WAS A 2CM LENGTH STRAIGHT SEGMENT OF THE BIFURCATE BARE SPRING WHICH HAD FRACTURED AND SEPARATED; IT WAS POSITIONED APPROXIMATELY 2CM BELOW THE RENALS ON THE LEFT SIDE OF THE PROXIMAL NECK/AAA. THE CAUSE OF THE FRACTURE IS UNCERTAIN; IT IS POSSIBLE THAT DISEASE PROGRESSION (ANGULATED NECK) AND MORPHOLOGY CHANGES MAY HAVE CONTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86116 TALENT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00191537

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention