BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT

    MDR report key: 4232897 · Received November 6, 2014

    Report

    Report Number
    2953200-2014-02336
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    December 11, 2013
    Report Date
    October 24, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, CONCLUSIONS: OFF-LABEL, UNAPPROVED, OR CONTRAINDICATED USE (NECK DIAMETER <(> <<)>19MM).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: NO OTHER STENTS WERE IMPLANTED EITHER PRE AND POST-IMPLANT. THE PROXIMAL NECK DIAMETER AT IMPLANT IS 16-15-17-15MM. FILM HAVE BEEN EVALUATED: THIS OBJECT IS AN ENDURANT STENT; IT APPEARS THAT THE PROXIMAL STENT FROM THE CONTRALATERAL LIMB WAS SOMEHOW RIPPED PARTIALLY OFF OF THE GRAFT MATERIAL AND PULLED DOWN INTO THE IPSILATERAL SIDE OF THE GRAFT. THERE WAS NO REPORT OF ANY DEPLOYMENT OR WITHDRAWAL DIFFICULTIES WITH THE CASE, OR ANY OTHER ABNORMALITY DURING THE PROCEDURE. AT THIS TIME IT IS UNKNOWN HOW THIS COULD HAVE HAPPENED WITHOUT A FAIRLY SIGNIFICANT DOWNWARD FORCE EXERTED ON THE CONTRALATERAL LIMB PROXIMAL STENT TOWARDS THE IPSILATERAL LUMEN. AS A RESULT OF THE STENT BEING PARTIALLY PULLED OFF OF THE GRAFT, THE CONTRALATERAL LIMB LUMEN OPENING APPEARS TO BE RESTRICTED DOWN TO ~5-6 MM DIAMETER.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 45 MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM, WITH A PRE-OPERATIVE DISSECTION PROXIMALLY. THE RIGHT COMMON ILIAC ARTERY HAS CALCIFICATION; THE LEFT COMMON ILIAC ARTERY HAS STENOSIS. IT WAS REPORTED THAT FROM THE FOLLOW-UP CT SCAN FROM THE INDEX PROCEDURE SHOW AN UNKNOWN OBJECT WAS FOUND WITHIN THE IPSILATERAL LIMB OF THE BIFURCATED TYPE ENDURANT. THE PHYSICIAN BELIEVES THAT IT IS A STRUT OF THE ENDURANT STENT-GRAFT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS GOOD. A REVIEW OF RETURNED CTA¿S FROM 5 DAY¿S POST-IMPLANT REVEALED THAT THE BIFURCATE WAS POSITIONED JUST BELOW THE RENAL ARTERIES. THE IPSILATERAL LIMB WAS PLACED INTO THE LEFT COMMON ILIAC AND THE CONTRALATERAL LIMB INTO THE RIGHT COMMON ILIAC. WITHIN THE IPSILATERAL LIMB, BEGINNING APPROXIMATELY 5MM BELOW THE FLOW DIVIDER, A 1CM LENGTH ¿Z-SHAPED¿ OBJECT WAS SEEN WITHIN THE LUMEN OF THE LIMB. THE OBJECT HAS SIMILAR WIRE DIAMETER AND REFLECTANCE OF AN ENDURANT STENT. THE IPSILATERAL LIMB IS ESSENTIALLY STRAIGHT IN THIS LOCATION AND NO OBVIOUS MISSING STENTS OR OTHER ISSUES ARE SEEN WITH THE STENT GRAFT NEAR TO WHERE THIS FOREIGN OBJECT IS SEEN. THE STENT GRAFT IS PATENT. WITHIN THE LEFT COMMON ILIAC ARTERY, APPROXIMATELY 1CM DISTAL TO THE DISTAL END OF THE IPSILATERAL LIMB, THE COMMON ILIAC IS NARROWED DOWN FROM 15MM TO 7MM ID. THE CAUSE OF THE UNKNOWN OBJECT SEEN WITHIN THE LIMB IS UNCERTAIN. PRE-IMPLANT AND INTRA-OP IMAGES WERE NOT PROVIDED. IT IS POSSIBLE THAT ANOTHER STENT (PLACED PREVIOUS OR AFTER THE IMPLANT) MAY HAVE BEEN BEC OME TRAPPED WITHIN THE LIMB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713683 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03990602

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR