BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3254114 · Received July 30, 2013

    Report

    Report Number
    2953200-2013-01474
    Event Type
    Injury
    Date Received
    July 30, 2013
    Date of Event
    August 13, 2013
    Report Date
    September 5, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: FILM EVALUATION. RESULTS, CONCLUSIONS: DISEASE PROGRESSION. CAUSE OF THROMBUS IS UNKNOWN. EVALUATION CODES,

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH COIL EMBOLIZATION AND PLACEMENT OF STENT GRAFT EXTENSIONS (161682 AND A 202082), THE TYPE IB ENDOLEAK RESOLVED. THE INVESTIGATOR ASSESSMENT STATES THAT THE EVENT IS RELATED TO THE STUDY DEVICE; HOWEVER, IT IS NOT RELATED TO THE STUDY PROCEDURE.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 8.6 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. PROXIMAL NON-ANEURYSMAL AORTIC NECK DIAMETER, IMMEDIATELY BELOW THE LOWEST RENAL IS 27 MM. DISTAL NON-ANEURYSMAL AORTIC NECK DIAMETER IMMEDIATELY ABOVE ANEURYSM IS 27 MM. DISTAL DIAMETER OF AORTA/ANEURYSM ABOVE THE AORTIC BIFURCATE WAS 32 MM. PROXIMAL DIAMETER OF NON-ANEURYSMAL NECK OF THE RIGHT ILIAC ARTERY IS WAS 16 MM. DIAMETER OF NON-ANEURYSMAL NECK OF THE RIGHT ILIAC ARTERY WAS 18 MM. DISTAL DIAMETER OF NON-ANEURYSMAL NECK OF THE RIGHT ILIAC ARTERY WAS 18 MM. DIAMETER OF ACCESS VESSELS, TIGHT FEMORAL ARTERY WAS 11 MM. PROXIMAL DIAMETER OF AN ANEURYSM NECK OF THE LEFT ILIAC ARTERY 15 MM. DIAMETER OF NON-ANEURYSMAL NECK OF THE LEFT ILIAC ARTERY WAS 16 MM. DISTAL DIAMETER OF NON-ANEURYSMAL NECK OF THE LEFT ILIAC ARTERY WAS 17 MM. LENGTH OF THE NON-ANEURYSM AORTIC NECK WAS 37 MM. LENGTH FROM LOWEST RENAL ARTERY TO AORTIC BIFURCATION 113 MM. LENGTH OF PORTION OF RIGHT (56 MM) AND LEFT ILIAC (50 MM) FROM AORTIC BIFURCATION TO THE END SEAL ZONE. RIGHT AND LEFT ILIAC TORTUOSITY WAS REPORTED AS MODERATE. IT WAS REPORTED THAT THE PATIENT WAS NOTED TO HAVE A TYPE IB ENDOLEAK OF THE RIGHT LIMB. THE ANEURYSM WAS 55 MM IN DIAMETER. THE PATIENT HAD AN UNKNOWN SECONDARY INTERVENTION. THE INVESTIGATOR ASSESSMENT STATES THAT THE EVENT IS RELATED TO THE DEVICE AND NOT THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    FILMS WERE REVIEWED, CTA FROM 4 YEAR FOLLOW-UP SHOW THE BIFURCATE POSITIONED JUST BELOW THE RENAL ARTERIES. THE IPSILATERAL LIMB WAS POSITIONED INTO THE RIGHT COMMON ILIAC, WHICH WAS ANEURYSMAL (3.5CM DIAMETER), AND THERE IS A DISTAL TYPE I ENDOLEAK. THE DISTAL IPSILATERAL LIMB OD IS 20 X 23, AND THE RIGHT ILIAC MEASURES 30MM IN THIS LOCATION. THE CONTRALATERAL LIMB WAS POSITIONED WITHIN THE LEFT COMMON ILIAC WITH NO ENDOLEAK. THE MAX DIAMETER AAA IS 8CM; NO CONTRAST IS SEEN WITHIN THE AAA. THERE IS SOME THROMBUS SEEN LINING THE ID OF THE BIFURCATE AORTIC BODY, AS WELL AS WITHIN THE DISTAL PORTION OF THE IPSILATERAL LIMB. NO THROMBUS IS SEEN WITHIN THE CONTRALATERAL LIMB. THE REPORTED "LOOSE GRAFT FABRIC IN THE RIGHT ILIAC" CANNOT BE SEEN; THERE IS CALCIFICATION OBSERVED IN THE RCIA. THE CAUSE OF THE DISTAL TYPE I APPEARS TO BE DUE TO DISEASE PROGRESSION. THE CAUSE OF THE THROMBUS SEEN IN THE IPSILATERAL LIMB IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354498 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR V00337276

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention