BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT SYSTEM

    MDR report key: 2141213 · Received June 22, 2011

    Report

    Report Number
    2953200-2011-01178
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    May 23, 2011
    Report Date
    November 14, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: ENDOLEAK. CAUSE OF THE TYPE III ENDOLEAK IS UNKNOWN. CONCLUSION: CAUSE OF THE TYPE III ENDOLEAK IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FOR THIS CASE. IT WAS REPORTED THAT THE PATIENT RESENTED WITH A GROWING ANEURYSM AND AN OBVIOUS TYPE III ENDOLEAK (GRAFT) COMING FROM THE RIGHT LIMB (IPSILATERAL). THE PHYSICIAN PLACED AN ENDURANT ILIAC LIMB UP TO THE FLOW DIVIDER ON THE RIGHT AND THE TYPE III ENDOLEAK WAS RESOLVED.

    Description of Event or Problem · 1

    AT ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 10 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNKNOWN. IT WAS REPORTED THAT AN ANEURX BIFURCATED STENT GRAFT (MFR REPORT # 2953200-2011-01178) AND CONTRALATERAL LIMB (MFR REPORT # 2953200-2011-01179) WERE IMPLANTED. THE PATIENT'S FOLLOW-UP HISTORY IS UNKNOWN, ALTHOUGH AT ONE TIME, THE ANEURYSM SIZE MAY HAVE DECREASED TO 3.2 CM IN DIAMETER. APPROXIMATELY 1 MONTH AGO, THE PATIENT PRESENTED EMERGENTLY WITH PAIN, AND IT WAS NOTED THAT THERE WAS SOME CONTRAST LEAKING BETWEEN THE CONTRALATERAL LIMB AND THE MAIN BODY AT THE GATE; HOWEVER, THERE WAS NOT A COMPLETE COMPONENT SEPARATION. AS A RESULT, THE ANEURYSM HAD ENLARGED IN SIZE, BUT THE ANEURYSM DIAMETER AT THE TIME OF THE JUNCTIONAL TYPE III ENDOLEAK IS UNKNOWN. THE AORTIC NECK WAS STRAIGHT, AND THE STENT GRAFT WAS CLOSE TO THE RENALS. THE CAUSE OF THE TYPE III ENDOLEAK IS UNKNOWN. THE PHYSICIAN ELECTED TO INTERVENE BY PLACING A 16X16X82 ENDURANT LIMB TO RELINE THE GATE AREA WITH GOOD RESULTS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention