BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX STENT GRAFT SYSTEM

    MDR report key: 2832663 · Received November 14, 2012

    Report

    Report Number
    2953200-2012-02186
    Event Type
    Death
    Date Received
    November 14, 2012
    Date of Event
    October 26, 2013
    Report Date
    December 17, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS/CONCLUSIONS: UNKNOWN CAUSE OF DEATH, DEATH.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION FOR THE PROXIMAL TYPE I ENDOLEAK WAS RECEIVED ON (B)(4), 2012; HOWEVER THE NOTIFY DATE FOR THE PREVIOUS MDR STATES (B)(4), 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TYPE IA ENDOLEAK WAS DISCOVERED FROM THE PROXIMAL END OF THE CONVERTER STENT GRAFT. THE ENDOLEAK WAS SEEN A CT THAT WAS DONE APPROXIMATELY TWO WEEKS POST IMPLANT. NO INTERVENTION WAS PERFORMED. THE PATIENT IS FINE.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. CURRENTLY THE VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK 31 MM IN DIAMETER AT THE RENAL ARTERIES, THE AORTIC NECK WAS 2.5 CM IN LENGTH. THE CURRENT SIZE OF THE ANEURYSM IS 5.3 CM IN DIAMETER. A RECENT CT DEMONSTRATED THAT THE STENT GRAFT HAS MIGRATED DISTALLY 2.5 CM WITH A TYPE I ENDOLEAK. THE CAUSE OF THE MIGRATION IS DUE TO DISEASE PROGRESSION AND AORTIC NECK DILATATION. THE PHYSICIAN ELECTED TO IMPLANT A TALENT CONVERTER EXTENDED THE TALENT CONVERTER STENT GRAFT WITH AN ILIAC LIMB AND A TALENT OCCLUDER DEVICE WAS IMPLANTED AND PERFORMED A FEMORAL TO FEMORAL BYPASS WAS PERFORMED. THE MIGRATION AND TYPE I ENDOLEAK WERE RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF DEATH WAS DUE TO A CARDIAC ARREST. THE INVESTIGATOR ASSESSED THIS EVENT AS NOT DEVICE OR PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA 1000790

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Death| R