BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 3871998 · Received June 13, 2014

    Report

    Report Number
    2953200-2014-01190
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    October 9, 2012
    Report Date
    May 20, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP A DISTAL ENDOLEAK WAS DETECTED APPROXIMATELY 53 MONTHS POST IMPLANT AND WAS SUCCESSFULLY RESOLVED BY IMPLANT OF THE TWO ENDURANT LIMBS. THE CAUSE OF THE DISTAL TYPE I ENDOLEAK WAS DUE TO DISEASE PROGRESSION. AT APPROXIMATELY 60 MONTHS POST IMPLANT, THE BIFURCATED STENT GRAFT WAS FOUND TO HAVE MIGRATED DISTALLY APPROXIMATELY 2 CM AND THERE WAS AN APPARENT PROXIMAL TYPE I ENDOLEAK. THE MIGRATION WAS DUE TO DISEASE PROGRESSION. A (B)(4) ENDURANT CUFF WAS USED. APTUS COILS WERE ALSO USED TO SECURE BOTH THE BIFURCATED STENT GRAFT AND THE ENDURANT CUFF STENT GRAFTS TOGETHER. AN ANGIOGRAM SHOWED THE ENDOLEAK WAS NOT RESOLVED AND WAS STILL BRISK AND APPARENT AT THE LEVEL OF THE FLOW DIVIDER. A SECOND ENDURANT (B)(4) WAS PLACED LOWER JUST PROXIMAL TO THE FLOW DIVIDER. ANOTHER ANGIOGRAM SHOWED THE ENDOLEAK WAS STILL PRESENT AND BRISK. A RELIANT BALLOON WAS PLACED WITHIN THE GRAFT IN MULTIPLE LOCATIONS IN AN ATTEMPT TO ISOLATE THE ENDOLEAK. IT WAS DETERMINED THAT THE ENDOLEAK WAS A TYPE III ENDOLEAK COMING FROM THE PROXIMAL LEFT COMMON LIMB. THE CAUSE OF THE TYPE III ENDOLEAK IS UNKNOWN. A (B)(4)ENDURANT WAS PLACED AT THAT LOCATION AND RESOLVED THE ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. REVIEW OF RETURNED FILMS DURING A SECONDARY ANGIOGRAM CONFIRMED THAT AN ANEURX STENT GRAFT SYSTEM, INCLUDING AN AORTIC CUFF, WERE POSITIONED APPROXIMATELY 2CM BELOW THE RENALS. AN ENDURANT AORTIC CUFF WAS THEN SEEN PLACED JUST BELOW THE LEVEL OF THE RENALS OVERLAPPING THE MIGRATED ANEURX CUFF. APTUS COILS WERE ALSO OBSERVED BETWEEN THE ANEURX AND ENDURANT AORTIC CUFF. WITH A BALLOON INFLATED WITHIN THE ORIGIN OF THE CONTRALATERAL LIMB JUST BELOW THE LEFT SIDE OF THE FLOW DIVIDER, CONTRAST WAS SEEN COMING FROM THE RIGHT SIDE NEAR THE LEVEL OF THE BIFURCATE FLOW DIVIDER AND THE IPSILATERAL LIMB ORIGIN. THE SAME CONTRAST WAS ALSO SEEN AFTER BALLOONING AND INJECTING JUST BELOW THE IPSILATERAL LIMB ORIGIN. THIS APPEARED TO BE A TYPE III FABRIC ENDOLEAK;, HOWEVER THE CAUSE OF THE ENDOLEAK COULD NOT BE DETERMINED FROM THESE IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350851 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA 1000022Y

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention