BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3163577 · Received June 11, 2013

    Report

    Report Number
    2953200-2013-01103
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    October 26, 2012
    Report Date
    June 3, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHODS: FILMS. RESULTS: ENDOLEAK. ANATOMY RELATED; TYPE 2 ENDOLEAK. INSUFFICIENT INFORMATION; CAUSE OF TYPE 3 ENDOLEAK IS UNKNOWN. CONCLUSIONS: ENDOLEAK. INSUFFICIENT INFORMATION; CAUSE OF TYPE 3 ENDOLEAK IS UNKNOWN.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A SYMPTOMATIC FUSIFORM ABDOMINAL AORTIC ANEURYSM AND A RIGHT ILIAC ANEURYSM. THE ILIAC STENT GRAFTS WERE IMPLANTED PROXIMAL TO THE INTERNAL ILIAC ARTERIES BILATERALLY. THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM WAS 100MM. THE PROXIMAL AORTIC NECK WAS 24-22.3MM IN DIAMETER AND 25.6MM LONG, WITH AN INFRA-RENAL NECK ANGLE OF 39.6 DEGREES. THE DISTAL AORTA WAS 48.4 MM IN DIAMETER. THE LEFT ILIAC ARTERY WAS 14.1-13.6-15.8 MM IN DIAMETER. THE DIAMETER OF THE LEFT FEMORAL ARTERY WAS 9.9MM. THE DIAMETER OF THE RIGHT ILIAC ANEURYSM WAS 22.3MM, AND THE LENGTH WAS 56.3MM. THE DIAMETER OF THE RIGHT FEMORAL ARTERY WAS 11.9MM. THE RIGHT AND LEFT ILIAC ARTERIES WERE MODERATELY TORTUOUS WITH NO STENOSIS. THE CIRCUMFERENTIAL AORTIC MURAL THROMBUS/CALCIFICATION AT THE PROXIMAL NECK WAS 5%. IT WAS REPORTED THAT A TYPE II ENDOLEAK WAS FIRST OBSERVED ON FOLLOW-UP IMAGING ONE YEAR POST INDEX PROCEDURE. THIS ENDOLEAK HAS REMAINED UNCORRECTED. TWO YEARS POST INDEX PROCEDURE, ULTRASOUND AND CT REVEALED A TYPE III ENDOLEAK COMING FROM THE LEFT LIMB. THE PHYSICIAN ASSESSED THE SOURCE OF THE ENDOLEAK TO BE A TEAR IN THE STENT GRAFT FABRIC. THE DIAMETER OF THE AORTIC ANEURYSM WAS NOTED TO BE 111MM AT THIS TIME. THE LEFT CONTRALATERAL LIMB WAS RELINED WITH AN ENDURANT 1616156, AND THE TYPE III ENDOLEAK WAS EXCLUDED. THE INVESTIGATOR ASSESSED THE TYPE III ENDOLEAK TO BE RELATED TO THE DEVICE BUT NOT RELATED TO THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. A REVIEW OF FILMS 2-YEARS POST-IMPLANT SHOWED THE BIFURCATE POSITIONED JUST BELOW THE RENALS. THE NECK IS VERY SHORT (<1CM) AND ANGULATED APPROXIMATELY 40DEG (A-P) X 55DEG (L-R). ONE OF THE SUPRARENAL STENTS (ANTERIOR) APPEARS TO BE FOLDED INWARD APPROX 45DEG AND UNOPPOSED TO THE AORTIC WALL; NO FABRIC INFOLDING OR PROXIMAL TYPE I ENDOLEAK IS SEEN. THE STENT GRAFT WAS PLACED WITH THE IPSILATERAL LIMB AND EXTENSION INTO THE RIGHT COMMON ILIAC ARTERY. CONTRAST IS SEEN COMING PRIMARILY FROM THE ANTERIOR SIDE OF THE (LEFT) CONTRALATERAL LIMBS NEAR THE MID-LENGTH OF THE AAA SAC. THIS APPEARS TO BE A TYPE III JUNCTIONAL ENDOLEAK, WITH PARTIAL LIMB DISCONNECTION BETWEEN THE CONTRALATERAL EXTENSION AND THE CONTRALATERAL LIMB. THE CAUSE OF THE ENDOLEAK COULD NOT BE DETERMINED; THE STENT GRAFT IS ESSENTIALLY STRAIGHT IN THIS LEAK LOCATION, BUT IS ACUTELY ANGULATED POSTERIORLY JUST DISTAL TO THE ENDOLEAK. THERE ALSO APPEARS TO BE A POSSIBLE TYPE II ENDOLEAK IN THE DISTAL SAC. THE MAXIMUM AAA DIAMETER IS 11CM. BOTH LIMBS ARE PATENT. THE CAUSE OF THE TYPE III ENDOLEAK COULD NOT BE DETERMINED. EARLIER POST-IMPLANT IMAGES WERE NOT PROVIDED AND AN ASSESSMENT OF POSSIBLE IN-VIVO CONFIGURATION CHANGES OVER THE IMPLANT DURATION COULD NOT BE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264114 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00488965

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention