BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT CAPTIVIA FF

    MDR report key: 5733203 · Received June 17, 2016

    Report

    Report Number
    2953200-2016-01244
    Event Type
    Malfunction
    Date Received
    June 17, 2016
    Date of Event
    August 18, 2016
    Report Date
    October 10, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FILM EVALUATION RESULTS ARE: THE CAUSE OF THE FRACTURED PROXIMAL BARE SPRING OBSERVED ON THE TALENT STENT GRAFT COULD NOT BE DETERMINED FROM THE FILMS PROVIDED. THIS MAY HAVE BEEN FATIGUE RELATED. NO OBVIOUS ENDOLEAK, ADDITIONAL FRACTURES, OR OTHER ISSUES WERE SEEN WITH THE THORACIC DEVICES. THE ANALYSIS OF THE RETURNED ANGIO¿S DID NOT REVEAL ANY STENT GRAFT CHARACTERISTICS THAT COULD EXPLAIN THE CAUSE OF THE FRACTURE. THE ANATOMY AT IMPLANT IS UNKNOWN, AND THE FOLLOW-UP CT¿S PROVIDED WERE NON-CONTRAST THEREBY NOT ALLOWING FOR ASSESSMENT OF ANY ENDOLEAK OR OTHER POSSIBLE ISSUES VIA EARLIER CT¿S. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX, DATE OF BIRTH. 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 THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT, APPROXIMATELY FOUR YEARS AND SEVEN MONTHS POST INDEX PROCEDURE AN ANGIOGRAM REVEALED THAT THE PROXIMAL BARE SPRING OF THE TALENT AORTIC STENT GRAFT HAD PARTIALLY DETACHED FROM THE FABRIC. THE PHYSICIAN ELECTED NOT TO INTERVENE. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS UNKNOWN. NO SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO AN UNKNOWN ENDOLEAK. THE PATIENT RECEIVED AN INTERVENTION; HOWEVER, THE ENDOLEAK DID NOT RESOLVE. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED BY THEIR PHYSICIAN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 58 MONTHS POST IMPLANT. THE PATIENT HAD THORACIC AND ABDOMINAL ANEURYSMS. THE PATIENT WAS TREATED FOR THE THORACIC ANEURYSM WITH TALENT THORACIC CAPTIVIA DEVICES AND THE ABDOMINAL ANEURYSM WITH AN ENDURANT BIFURCATED STENT GRAFT AND TALENT THORACIC CUFF. IT WAS REPORTED THAT THE PATIENT HAD PROXIMAL TYPE I ENDOLEAKS IN BOTH THE THORACIC AND ABDOMINAL ANEURYSMS. THE TALENT THORACIC PROXIMAL TYPE I ENDOLEAK WAS NOT TREATED AT THIS TIME AND THE TALENT STENT GRAFTS REMAIN IN THE PATIENT. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387895 TALENT CAPTIVIA FF SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND TF4646C157CP

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R