BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 2889750 · Received December 28, 2012

    Report

    Report Number
    2953200-2012-02512
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    January 25, 2013
    Report Date
    February 21, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHODS: FILMS. RESULTS: OCCLUSION. DISEASED NARROW DISTAL AORTA. CONCLUSION: DISEASED NARROW DISTAL AORTA.

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION, METHODS: (FILMS). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; SHORT AND ANGULATED PROXIMAL AORTIC NECK). EVALUATION, CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; SHORT AND ANGULATED PROXIMAL AORTIC NECK).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.5 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT HAD A SHORT CONICAL NECK. THE PROXIMAL NECK DIAMETER WAS APPROXIMATELY 25MM. THE PROXIMAL NECK ANGULATED 60 DEGREES (A-P), AND 45DEG (RIGHT - LEFT). IT WAS REPORTED THAT THE FINAL ANGIOGRAM REVEALED A PROXIMAL TYPE I ENDOLEAK OF THE BIFURCATED STENT GRAFT. THE PROXIMAL TYPE I ENDOLEAK WAS LEFT UNCORRECTED. THE PHYSICIAN WILL MONITOR THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. THE REVIEW OF FILMS PRE-IMPLANT SHOW THAT THE PROXIMAL NECK DIAMETER WAS APPROXIMATELY 25MM. THE PROXIMAL NECK ANGULATED 60 DEGREES (A-P), AND 45DEG (RIGHT - LEFT). THE 6.5CM MAX AAA WAS FILLED WITH THROMBUS (2.5CM LUMEN) AND CONTAINED SOME CALCIFICATION. THE ILIACS WERE SEVERELY CALCIFIED BILATERALLY. A SINGLE ANGIOGRAM FILM AT IMPLANT SHOWS THAT THE BIFURCATE IPSILATERAL LIMB WAS PLACED IN THE RIGHT ILIAC, CROSSING OVER THE CONTRA LIMB. THERE WAS A LIKELY PROXIMAL TYPE I ENDOLEAK NEAR THE MID-LENGTH OF THE BIFURCATE AORTIC BODY. NO OTHER STENT GRAFT ISSUES WERE SEEN. IT IS POSSIBLE THAT THE ANGULATED NECK, SEEN IN PRE-IMPLANT CTA, MAY HAVE CONTRIBUTED TO THE ENDOLEAK.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: IT WAS REPORTED THAT THE PROXIMAL TYPE I ENDOLEAK SELF-RESOLVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: IT WAS REPORTED THAT A RECENT FILM REVIEW REVEALED THAT THE BIFURCATED STENT GRAFT 2816124, THE CONTRALATERAL LIMB 1610124 AND THE CONTRALATERAL EXTENSION 161082 WERE OCCLUDED. THE NATIVE ILIAC ARTERY WAS DISEASED AND NARROW IN DIAMETER PRIOR TO THE INITIAL IMPLANTATION. THE PHYSICIAN STATED THAT THE OCCLUSION STARTED IN THE NATIVE ARTERY. DUE TO THE LOW BLOOD FLOW AND NARROW IN DIAMETER DISTAL AORTA THE STENT GRAFTS BECAME OCCLUDED STARTING IN THE NATIVE ARTERY UP TO THE AORTIC BIFURCATION OF THE BIFURCATED STENT GRAFT. THE PHYSICIAN PERFORMED A FEMORAL TO FEMORAL BYPASS AND THE BLOOD FLOW WAS RESTORED TO THE LOWER EXTREMITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01123701

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention