BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT STENT GRAFT SYSTEM

    MDR report key: 2823356 · Received November 7, 2012

    Report

    Report Number
    2953200-2012-02156
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 15, 2011
    Report Date
    November 27, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (ANEURYSM ENLARGEMENT). (UNKNOWN CAUSE OF ANEURYSM ENLARGEMENT). CONCLUSION: (UNKNOWN CAUSE OF ANEURYSM ENLARGEMENT).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHODS: (FILMS). RESULTS: INHERENT RISK OF PROCEDURE (MIGRATION). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DISEASE PROGRESSION, TYPE II ENDOLEAK). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (DISEASE PROGRESSION, TYPE II ENDOLEAK).

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED AND THE ANALYSIS HAS BEEN COMPLETED. THE DEVICE WAS EXPLANTED DURING SURGICAL CONVERSION DUE TO CONTINUED AAA SAC ENLARGEMENT. EXAMINATION OF THE RETURNED DEVICES COULD NOT DETERMINE THE CAUSE OF THE ANEURYSM EXPANSION. ONLY A PORTION OF THE EXPLANTED DEVICE, A 2-STENT RING SECTION OF THE BIFURCATE FLOW DIVIDER AND CONTRA LIMB, WERE RETURNED FOR EVALUATION; THEREBY LIMITING THE EXTENT OF THE EVALUATION. THE TRANSECTED PORTIONS OF THE PROXIMAL AORTIC BODY AND BARE SPRING, AND BOTH ILIAC LIMBS, WERE NOT RETURNED. MULTIPLE ALIGNED SMALL ABRASION OR PUNCTURE HOLES, 0.2MM - 0.6MM IN LENGTH, WERE SEEN ON THE CONTRALATERAL STUB AREA OF THE BIFURCATE. THE CAUSE OF THE HOLES APPEARS TO BE ABRASION RELATED FROM THE UNDERLYING CONTRALATERAL LIMB. IT IS POSSIBLE THAT THESE HOLES MAY HAVE CONTRIBUTED TO THE AAA EXPANSION. HOWEVER, NO ENDOLEAK WAS REPORTED IN THIS AREA, THE MAJORITY OF THE HOLES APPEARED COVERED BY TISSUE/THROMBUS IN THE "AS RECEIVED" CONDITION, AND THE HOLES WERE ALSO LIKELY COVERED IN-VIVO BY THE UNDERLYING CONTRALATERAL LIMB PLACED WITHIN THE STUB. NO OTHER STENT GRAFT INTEGRITY ISSUES WERE SEEN.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPH OLOGY WAS NOT REPORTED. THE PATIENT HAS CONTINUED ANEURYSM SAC ENLARGEMENT. THE PHYSICIAN HAS ELECTED TO EXPLANT THE STENT GRAFTS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    FILMS FROM THE 4-YEAR FOLLOW-UP WERE REVIEWED. THE TALENT BIFURCATED STENT GRAFT WAS IMPLANTED WITH THE IPSILATERAL LIMB ON THE LEFT SIDE; THE BIFURCATED STENT GRAFT IS CURRENTLY APPROXIMATELY 15MM BELOW THE LOWEST LEFT RENAL. THE AORTA DIAMETER AT THE RENAL ARTERIES IS 28MM. THE STENT PROXIMAL GRAFT DIAMETER IS 31 - 32MM. SEVERAL AREAS OF BRIGHT REFLECTANCE (POSSIBLY COILS) ARE SEEN WITHIN THE AAA SAC NEAR THE CONTRA LIMB; THE AAA CURRENTLY MEASURES 7.6 CM MAXIMUM. THERE IS GOOD DISTAL SEALING IN THE ILIACS; BILATERALLY. NO STENT GRAFT OCCLUSION, THROMBUS OR KINKS ARE VISIBLE. NO OBVIOUS ENDOLEAK IS SEEN; HOWEVER, DIFFICULT TO DISCERN ANY POSSIBLE CONTRAST/ENDOLEAK IN THE VICINITY OF THE COILS WITHIN THE ANEURYSM SAC. IMAGES FROM 5-YEAR FOLLOW-UP SHOW SIMILAR FINDINGS TO THE PRIOR YEAR. THE AAA HAS SLIGHTLY INCREASED TO APPROXIMATELY 8CM MAXIMUM. THERE IS A POSSIBLE AREA OF CONTRAST (SMALL CLOUDY AREA) NEAR THE COILS, ALONG THE POSTERIOR OF THE AAA SAC, APPROXIMATELY 3CM BELOW THE FLOW DIVIDER, NOT IN CONTACT WITH THE STENT GRAFT. THIS MAY BE A TYPE II ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR AF2816C155AX 941688

    Patients

    Seq Age Sex Outcome Treatment
    1