BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC

    MDR report key: 3052491 · Received April 11, 2013

    Report

    Report Number
    2953200-2013-00663
    Event Type
    Death
    Date Received
    April 11, 2013
    Date of Event
    February 23, 2013
    Report Date
    March 15, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM 6.5 CM THORACIC AORTIC ANEURYSM. THE PROXIMAL AORTA WAS 38-40 MM IN DIAMETER AND 38 MM IN LENGTH. THE DISTAL AORTA WAS 38-42 MM IN DIAMETER. THERE WAS A TYPE II ENDOLEAK NOTED POST IMPLANT THAT WAS LEFT UNRESOLVED. AT THE ONE MONTH FOLLOW-UP THE MAXIMUM ANEURYSM DIAMETER WAS 7.5 CM. THE TYPE II ENDOLEAK WAS STILL PRESENT. AT THE SIX MONTH FOLLOW-UP, THE MAXIMUM ANEURYSM DIAMETER WAS 7.5 CM. THE TYPE II ENDOLEAK WAS STILL PRESENT. FOUR MONTHS LATER THE MAXIMUM ANEURYSM DIAMETER WAS 8.1 CM. THE TYPE II ENDOLEAK WAS STILL PRESENT. SIX MONTHS LATER, THE MAXIMUM ANEURYSM DIAMETER WAS 8.1 CM. THE TYPE II ENDOLEAK WAS STILL PRESENT. THE SOURCE OF THE TYPE II ENDOLEAK AT THE ABOVE FOLLOW-UPS WAS THE LEFT SUBCLAVIAN ARTERY. THE PATIENT WAS APPROACHED FOR A SURGICAL INTERVENTION WHICH THE PATIENT DECLINED. THE PATIENT'S AORTIC ANEURYSM CONTINUED TO EXPAND DUE TO THE TYPE II ENDOLEAK AND SUBSEQUENTLY LED TO ANEURYSM RUPTURE AND DEATH (EXACT DATE OF DEATH IS UNKNOWN). THE INVESTIGATOR ASSESSED THIS EVENT AS DEVICE AND PROCEDURE RELATED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156836 TALENT THORACIC SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00568020

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Death