BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2891907 · Received December 31, 2012

    Report

    Report Number
    2953200-2012-02540
    Event Type
    Injury
    Date Received
    December 31, 2012
    Date of Event
    December 3, 2012
    Report Date
    February 10, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: (FILM).

    Additional Manufacturer Narrative · 1

    (B)(4) RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK), PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (CALCIFIED VESSELS). CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (CALCIFIED VESSELS).

    Description of Event or Problem · 1

    FILM REVIEW FROM SEVERAL STILL ANGIO IMAGES AT IMPLANT SHOWS THAT THE IPSILATERAL LIMB AND IPSILATERAL EXTENSION EXTEND INTO THE RIGHT ILIAC (BELIEVED TO BE THE RCIA). AN ENDOLEAK IS SEEN IN THE AAA SAC NEAR THE BIFURCATE FLOW DIVIDER. THIS APPEARS TO BE A BLUSH TYPE IV ENDOLEAK COMING FROM THE BIFUR AND POSSIBLY THE CONTRALATERAL LIMB. THERE IS ALSO AN ENDOLEAK NOTED (BY ANOTHER ARROW) IN THE RIGHT ILIAC COMING FROM THE IPSILATERAL EXTENSION JUST DISTAL TO THE IPSILATERAL LIMB. IT IS UNCERTAIN IF THE CONTRAST SEEN IS FILLING AN ILIAC ANEURYSM, THE RIGHT INTERNAL ILIAC, OR A PERFORATED ILIAC ARTERY. THE TYPE OF ENDOLEAK COULD NOT BE DETERMINED FROM THIS SINGLE STATIC IMAGE; NO CINE IMAGES SHOWING THE ENDOLEAK WERE PROVIDED, AND NO IMAGES DURING BALLOONING WERE PROVIDED. THIS ENDOLEAK MAY BE A TYPE III FABRIC ENDOLEAK, BUT CANNOT RULE OUT A TYPE IV. POST-RELINING WITH AN EXTENSION OVERLAPPING THE ENDOLEAK AND EXTENDING TO THE DISTAL END OF THE IPSILATERAL EXTENSION APPEAR TO HAVE RESOLVED THE ENDOLEAK. POST-IMPLANT CTA'S WERE REVIEWED; THE CTA'S WERE NON-CONTRAST THEREFORE ANY POSSIBLE ENDOLEAK COULD NOT BE ASSESSED. NO OBVIOUS STENT GRAFT ISSUES WERE OBSERVED. ALTHOUGH SOME CALCIFICATION WAS SEEN IN THE AAA SAC; NO CALCIFICATION WAS OBSERVED WITHIN THE RIGHT COMMON ILIAC.

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. ANEURYSM MORPHOLOGY WAS NOT REPORTED. IT WAS REPORTED THAT A TYPE III ENDOLEAK, FABRIC, WAS OBSERVED INTRA-OPERATIVELY, WHICH WAS BELIEVED TO BE CAUSED BY A PUNCTURE IN THE STENT GRAFT MATERIAL. THE PHYSICIAN SUSPECTS THE PUNCTURE MAY HAVE BEEN CAUSED BY CALCIUM IN THE COMMON ILIAC. THE AREA OF THE LEAK WAS BALLOONED, BUT NOT MORE AGGRESSIVELY THAN USUAL. THE ENDOLEAK WAS REPAIRED BY PLACING A (B)(4) INSIDE THE EXISTING GRAFT. THE FINAL ANGIOGRAM REVEALED NO ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT II ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01720159

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention