BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 2031697 · Received March 18, 2011

    Report

    Report Number
    2953200-2011-00669
    Event Type
    Death
    Date Received
    March 18, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL, RESULTS: (DEATH). (PRE-OPERATIVE RUPTURE). (TREATMENT OF A PRE-OPERATIVE RUPTURED ANEURYSM). CONCLUSION: (PRE-OPERATIVE RUPTURE). (TREATMENT OF A PRE-OPERATIVE RUPTURED ANEURYSM).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN EMERGENCY PRE-OPERATIVE RUPTURED 7 CM DIAMETER ANEURYSM, ONE MONTH AGO. VESSEL MORPHOLOGY INCLUDED AN AORTIC NECK OF 29 - 31 MM IN DIAMETER AND APPROXIMATELY 1.4 CM LONG. IT WAS REPORTED THAT THE STENT GRAFT WAS IMPLANTED IN AN ATTEMPT TO SAVE THE PT'S LIFE AND THE ONLY SIZES AVAILABLE WERE 32 MM DIAMETER ENDURANT BIFURCATED STENT GRAFTS. THE FIRST BIFURCATED STENT GRAFT WAS IMPLANTED WITH THE PROXIMAL EDGE OF THE STENT GRAFT PARTIALLY COVERING THE RENAL ARTERIES. THE CONTRALATERAL LIMB WAS IMPLANTED; HOWEVER, THERE WAS A PROXIMAL TYPE 1 ENDOLEAK NOTED (REF MFR 2953200-2011-00667). A SECOND 32 MM DIAMETER ENDURANT BIFURCATED STENT GRAFT WAS IMPLANTED FROM THE CONTRALATERAL SIDE WITH THE TOP OF THE STENT GRAFT BELOW THE SMA. THIS STENT GRAFT WAS INTENTIONALLY COVERING THE RENAL ARTERIES IN AN ATTEMPT TO SEAL THE ANEURYSM. ANOTHER CONTRALATERAL LIMB WAS THEN DEPLOYED, BUT THE PT HAD LOST AN EXCESSIVE AMOUNT OF BLOOD AND EXPIRED (REF MFR 2953200-2011-00668). NO OTHER CLINICAL SEQUELAE WERE REPORTED. (REF MFR 2953200-2011-00670).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00305194

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death