BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AAA

    MDR report key: 3143504 · Received June 3, 2013

    Report

    Report Number
    2953200-2013-01049
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK, MIGRATION, REMOVAL OF IMPLANT) 317 PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; DISEASE PROGRESSION WITH AORTIC NECK DILATATION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; DISEASE PROGRESSION WITH AORTIC NECK DILATATION).

    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

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL AND ANEURYSM MORPHOLOGY AT THE TIME OF IMPLANT IS UNKNOWN. CURRENTLY THE ANEURYSM IS 10 CM IN DIAMETER. THE PATIENT WAS LOST TO FOLLOW-UP. THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL AND BACK PAIN. THERE IS DISEASE PROGRESSION WITH AORTIC NECK DILATATION. THE AORTIC NECK IS 40 CM IN DIAMETER. THE CT REVEALED THAT THE STENT GRAFT HAS MIGRATED INTO THE ANEURYSM SAC WITH A TYPE I ENDOLEAK PRESENT; THE EXACT DATE OF THE MIGRATION IS UNKNOWN. THE PHYSICIAN ELECTED TO PARTIALLY EXPLANT THE STENT GRAFT. THE STENT GRAFTS WERE CUT AT THE BIFURCATION AND BILATERALLY THE DISTAL PART OF THE STENT GRAFT LIMBS REMAIN IN THE PATIENT. THE ANEURX AORTIC CUFF REMAINS IN THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    THE RETURNED DEVICE ANALYSIS HAS BEEN COMPLETED. THE DEVICE WAS EXPLANTED DURING SURGICAL CONVERSION DUE TO AAA EXPANSION FROM A RECENTLY FOUND MIGRATED STENT GRAFT. DETAILS OF THE ANEURYSM MORPHOLOGY AT IMPLANT WERE NOT REPORTED, AND THE PATIENT WAS LOST TO FOLLOW-UP. THE PATIENT RECENTLY PRESENTED EMERGENTLY WITH ABDOMINAL AND BACK PAIN, AND CTA REVEALED THAT THE STENT GRAFT HAS MIGRATED INTO THE ANEURYSM SAC WITH A PROXIMAL TYPE I ENDOLEAK. THE CAUSE OF THE MIGRATION WAS DUE TO DISEASE PROGRESSION; THE AORTIC NECK DIAMETER HAD DILATED TO 40 MM. THE INITIAL DATE OF THE MIGRATION IS UNKNOWN. THE AAA DIAMETER MEASURED 10 CM AND THE DECISION WAS MADE TO EXPLANT THE STENT GRAFT DURING OPEN REPAIR. THE STENT GRAFTS WERE TRANSECTED AT THE AORTIC BIFURCATION AND THE DISTAL PORTION OF BOTH STENT GRAFT LIMBS WERE LEFT IN THE PATIENT. THE PATIENT WAS SUCCESSFULLY CONVERTED. FROM THE EXAMINATION OF THE RETURNED DEVICES THE LIKELY CAUSE OF THE STENT GRAFT MIGRATION, LEADING TO THE PROXIMAL TYPE I ENDOLEAK AND AAA EXPANSION, APPEARS TO BE DUE TO DISEASE PROGRESSION. THE DEVICES WERE RETURNED TRANSECTED AT THE ORIGIN OF THE IPSILATERAL LIMB AND AT THE MID-LENGTH OF EACH LIMBS. THE DISTALLY TRANSECTED LIMBS WERE NOT RETURNED AS THEY WERE REPORTEDLY LEFT IN THE PATIENT. THE BIFURCATE AORTIC BODY WAS FOUND TO HAVE MULTIPLE SPRING ABRASION TEARS, AND 2 ABRASION AND CREASE FATIGUE TEARS WERE ALSO SEEN NEAR THE MID-LENGTH OF THE IPSILATERAL LIMB. TWO CREASE FATIGUE TEARS WERE ALSO OBSERVED ALONG THE CONTRALATERAL LIMB; THE LIMB WAS RETURNED DETACHED FROM THE BIFURCATE GATE. ALTHOUGH IT IS POSSIBLE THESE FABRIC TEARS MAY HAVE CONTRIBUTED TO THE ANEURYSM EXPANSION, NO ENDOLEAK WAS REPORTED IN THESE AREAS, AND THE MAJORITY OF THE TEARS WERE OBSERVED ¿COVERED¿ BY TISSUE/THROMBUS IN THE AS RECEIVED CONDITION. SINCE THE INITIAL DATE OF THE MIGRATION IS UNKNOWN, IT IS ALSO POSSIBLE THAT THE TEARS MAY HAVE OCCURRED AFTER THE STENT GRAFT HAD MIGRATED INTO THE ANEURYSM SAC. FILMS IMMEDIATELY POST-IMPLANT WERE NOT AVAILABLE FOR REVIEW; THEREFORE, THE ASSESSMENT OF THE STENT GRAFT IN-VIVO CONFIGURATION OVER THE IMPLANT DURATION COULD NOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242925 TALENT AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00084850

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention