BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AAA

    MDR report key: 3100647 · Received May 8, 2013

    Report

    Report Number
    2953200-2013-00863
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK, ANEURYSM RUPTURE). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DISEASE PROGRESSION). EVALUATION CONCLUSIONS: INHERENT RISK OF A PROCEDURE (ENDOLEAK, ANEURYSM RUPTURE). DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (DISEASE PROGRESSION).

    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. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THE PATIENT HAD NOT RETURNED FOR ANY FOLLOW-UP VISITS SINCE THE STENT GRAFTS WERE IMPLANTED. THE PATIENT PRESENTED WITH ABDOMINAL PAIN. A CT SCAN WAS DONE IMMEDIATELY AND A CONTAINED RUPTURE WAS FOUND THAT WAS A RESULT OF A PROXIMAL TYPE I ENDOLEAK. THE ENDOLEAK WAS DUE TO DISEASE PROGRESSION AND THE AORTIC NECK MEASURED 28 MM PROXIMALLY AND THEN WENT TO 32 MM AND THEN 35 MM DISTALLY OVER A DISTANCE OF 9 MM. THE DECISION WAS MADE TO SURGICALLY REPAIR THE RUPTURED ANEURYSM AND THE PATIENT WAS TAKEN TO SURGERY. THE TOP PORTION OF THE BIFURCATED STENT GRAFT WHERE THE ENDOLEAK WAS COMING FROM WAS SURGICALLY REMOVED AND DISCARDED BY THE USER FACILITY. A DACRON GRAFT WAS SEWN ON TO THE AORTIC NECK PROXIMALLY AND TO THE BODY OF THE TALENT BIFURCATE DISTALLY. THE PATIENT TOLERATED THE PROCEDURE WELL. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201882 TALENT AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00213029

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention