BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANEURX

    MDR report key: 4200342 · Received October 24, 2014

    Report

    Report Number
    2953200-2014-02183
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    November 3, 2014
    Report Date
    November 3, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 FROM THE TIME OF IMPLANT ARE UNKNOWN. IT WAS REPORTED THAT A RECENT FOLLOW-UP CT SHOWED A POSSIBLE TYPE III ENDOLEAK AS A RESULT OF A STENT FRACTURE AND/OR SUTURE BREAK AT THE PROXIMAL END OF THE CONTRALATERAL LIMB. THE PHYSICIAN INDICATED THAT ALTHOUGH THE PATIENT IS ASYMPTOMATIC, THE ANEURYSM HAS BEEN ENLARGING. THE PHYSICIAN WAS UNABLE TO CONCLUDE WHY THIS OCCURRED; HOWEVER, MENTIONED SOME OF THE POTENTIAL CAUSE(S) MAY INCLUDE THE SUTURE ITSELF, SUTURE NOT PROPERLY SEWN, PATIENT ANATOMY CHANGING AND CREATING STRESS AT CERTAIN POINTS OF THE STENT GRAFT BUT THAT IT WOULD PROBABLY NEVER BE ABLE TO BE DETERMINED FOR CERTAIN. THE PHYSICIAN WILL MONITOR THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED. REVIEW OF CTA¿S 5+ YEARS POST-IMPLANT REVEALED THAT THE BIFURCATE WAS POSITIONED JUST BELOW THE RENAL ARTERIES. THE IPSILATERAL LIMB AND EXTENSION WERE PLACED INTO THE RIGHT COMMON ILIAC AND THE CONTRALATERAL LIMB INTO THE LEFT COMMON ILIAC ARTERY. THE BIFURCATE PROXIMAL STENT GRAFT OD IS 27MM. THE DISTAL IPSILATERAL LIMB EXTENSION MEASURES 19MM AND THE DISTAL CONTRALATERAL LIMB MEASURES 25MM. THE MAXIMUM AAA DIAMETER IS 6.7CM. CONTRAST IS SEEN WITHIN THE DISTAL SAC. THE ENDOLEAK IS LIKELY A TYPE III FABRIC ENDOLEAK COMING FROM THE CONTRALATERAL/LEFT LIMB NEAR THE DISTAL AORTA. THERE ARE ALSO POSSIBLE FRACTURED STENTS SEEN IN THE SAME ENDOLEAK LOCATION. THE CAUSE OF THE ENDOLEAK/FRACTURES IS UNCERTAIN. THE DISTAL CONTRALATERAL LIMB IS ANGULATED IN THIS DISTAL AORTIC LOCATION JUST PRIOR TO EXTENDING INTO THE LEFT COMMON ILIAC ARTERY. THE CAUSE OF THE STENT FRACTURE(S) MAY HAVE BEEN DUE TO ACUTE LIMB ANGULATION WHICH THEN CAUSED THE FABRIC HOLES AND EVENTUAL TYPE III FABRIC ENDOLEAK. EARLIER POST-IMPLANT IMAGES WERE NOT PROVIDED; THEREFORE THE STENT GRAFT IN-VIVO CONFIGURATION DURING THE IMPLANT DURATION COULD NOT BE ASSESSED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: THE PHYSICIAN IMPLANTED A 16/28/124 ENDURANT LIMB AND THIS SUCCESSFULLY RESOLVED THE ENDOLEAK AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680157 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00258184

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention