BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3132811 · Received May 29, 2013

    Report

    Report Number
    2953200-2013-01017
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 27, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION); (CAUSE OF OCCLUSION IS UNKNOWN). CONCLUSION: KNOWN INHERENT RISK OF A PROCEDURE (OCCLUSION); (CAUSE OF OCCLUSION IS UNKNOWN).

    Additional Manufacturer Narrative · 1

    METHOD: FILM EVALUATION. RESULTS: VESSEL TORTUOSITY. CONCLUSIONS: VESSEL TORTUOSITY.

    Description of Event or Problem · 1

    A REVIEW OF THE FILMS 1-MONTH POST-IMPLANT IMAGES SHOW THAT THE STENT GRAFT WAS IMPLANTED JUST BELOW THE RENALS. CONFIRMED THAT THE RIGHT IPSILATERAL LIMB AND RIGHT IPSI EXTENSION WERE OCCLUDED BEGINNING JUST ABOVE THE FLOW DIVIDER. THE CAUSE OF THE OCCLUSION IS UNCERTAIN, BUT MAY BE DUE TO THE STENT GRAFT NARROWING AND VESSEL TORTUOSITY. WITHIN THE 27 X 29MM DISTAL AORTA THE IPSI LIMBS ARE COMPRESSED DOWN TO APPROX 8MM MINIMUM. PERHAPS MORE CRITICALLY, THE 13MM IPSI EXTENSION GETS QUICKLY SQUEEZED DOWN TO ABOUT 6MM JUST AS IT MAKES A SHARP RIGHT LATERAL TURN INTO THE EXTERNAL ILIAC. THE MAX AAA DIAMETER IS 5.3CM AND THERE IS A TYPE II ENDOLEAK.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 47 MM IN DIAMETER AND 113 MM IN LENGTH FUSIFORM AAA. THE PROXIMAL NECK WAS 25MM IN DIAMETER AND 18MM IN LENGTH. THE LEFT COMMON ILIAC ARTERY WAS 16 MM IN DIAMETER AND THE RIGHT COMMON ILIAC ARTERY WAS 33 MM IN DIAMETER. THE RIGHT AND LEFT EXTERNAL ILIAC ARTERY MEASURED 10 MM IN DIAMETER. THE FINAL ANGIOGRAPHY SHOWED TYPE IV ENDOLEAK, BLUSH. THERE WERE NO SPECIFIC ISSUES DURING THE PROCEDURE AND IMPLANT AND THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT THE PATIENT WAS IN FOR THEIR FOLLOW UP AND A LIMB OCCLUSION WAS CONFIRMED. THE OCCLUSION OCCURRED WITHIN THE EXTENSION STENT GRAFT IN THE RIGHT. THE PATIENT HAD A FEMORAL FEMORAL BYPASS NINE DAYS LATER AND WILL BE DISCHARGED THIS WEEK. THE PHYSICIAN THINKS THAT THE CAUSE OF OCCLUSION IS EXTERNAL ILIAC ARTERY LANDING. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234030 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03032183

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Required Intervention