BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 3190793 · Received June 26, 2013

    Report

    Report Number
    2953200-2013-01204
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHODS: FILMS. RESULTS: INSUFFICIENT INFORMATION; CAUSE OF THE EVENTS ARE UNKNOWN. DISEASE PROGRESSION. CONCLUSIONS: INSUFFICIENT INFORMATION; CAUSE OF THE EVENTS ARE UNKNOWN. DISEASE PROGRESSION.

    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. THE ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF THE INDEX PROCEDURE ARE UNKNOWN. IT WAS REPORTED THAT THE PATIENT PRESENTED SYMPTOMATICALLY APPROXIMATELY 12 YEARS POST INDEX PROCEDURE WITH COMPLAINTS OF ABDOMINAL PAIN. THE PATIENT WAS NOT CURRENT WITH FOLLOW-UP VISITS. IMAGING REVEALED STENT FRACTURES ON THE POSTERIOR SIDE AT THE FLOW DIVIDER WITH A LARGE TYPE III FABRIC ENDOLEAK. THE ANEURYSM WAS ENLARGED TO APPROXIMATELY 11CM. THE PROXIMAL END OF THE BIFURCATED STENT GRAFT WAS NOTED TO BE APPROXIMATELY 1CM BELOW THE RENAL ARTERIES, BUT IT IS UNKNOWN IF THIS WAS THE ORIGINAL POSITION OR IF THE STENT GRAFT MIGRATED. THE PHYSICIAN ELECTED TO IMPLANT A 282849 ENDURANT CUFF TO INCREASE THE PROXIMAL SEAL. THEN TWO ENDURANT LIMBS (161693 ON THE RIGHT AND 1616124 ON THE LEFT) WERE PLACED SIMULTANEOUSLY TO CREATE A HIGHER FLOW DIVIDER. THE LIMBS WERE PLACED APPROXIMATELY 2.5 CM ABOVE THE EXISTING FLOW DIVIDER. A SHORT DISTAL SEAL WAS ALSO NOTED IN THE LEFT ILIAC ARTERY, BUT THERE WAS NO EVIDENCE OF A DISTAL TYPE I ENDOLEAK. AN ENDURANT 161682 CONTRALATERAL EXTENSION WAS IMPLANTED TO IMPROVE THE DISTAL SEAL IN THE LEFT COMMON ILIAC ARTERY. THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS DOING FINE. A REVIEW OF RETURNED FILMS POST IMPLANT SHOWED THAT THE STENT GRAFT WAS POSITIONED APPROXIMATELY 1CM BELOW THE RENALS, WITH 1CM OF REMAINING PROXIMAL NECK. THE OD OF THE STENT GRAFT AT THE PROXIMAL MARGIN IS CURRENTLY 24MM X 28MM. THE MAX AAA DIAMETER IS 11.5CM. THE AORTIC BODY AND LIMBS ARE ESSENTIALLY STRAIGHT. THERE IS CONTRAST SEEN WITHIN THE PROXIMAL AND MID-SAC. THE TYPE OF ENDOLEAK COULD NOT BE DETERMINED; MAY BE A PROXIMAL TYPE I, TYPE III FABRIC NEAR THE FLOW DIVIDER, OR BOTH. A SINGLE STILL ANGIO IMAGE SHOWED CONTRAST WITHIN THE SAC NEAR THE FLOW DIVIDER. THE TYPE OF ENDOLEAK COULD NOT BE DETERMINED FROM THIS STILL IMAGE. NO OBVIOUS STENT FRACTURES COULD BE SEEN. POST-SECONDARY IMAGES SHOWED THAT THE ENDOLEAK APPEARED RESOLVED FOLLOWING IMPLANT OF AN ENDURANT AORTIC CUFF AND BILATERAL LIMBS WITHIN THE AORTIC BODY AND IPSI/CONTRA LIMB ORIGINS. THE CAUSE OF THE ENDOLEAK COULD NOT BE DETERMINED. IMAGES AT EARLIER FOLLOW-UPS WERE NOT PROVIDED. IT IS POSSIBLE THAT DISEASE PROGRESSION MAY HAVE CONTRIBUTED TO THE MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290166 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR M00K550570

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention