BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 2912250 · Received January 11, 2013

    Report

    Report Number
    2953200-2013-00076
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    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). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANGULATED AORTIC NECK); INCORRECT TECHNIQUE/PROCEDURE (STENT GRAFT WAS USED IN A PATIENT WITH A SEVERELY ANGULATED AORTIC NECK). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANGULATED AORTIC NECK); OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (STENT GRAFT WAS USED IN A PATIENT WITH A SEVERELY ANGULATED AORTIC NECK).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60 MM DIAMETER X 61 MM LENGTH FUSIFORM SHAPED ABDOMINAL AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. THE PROXIMAL NECK WAS 28 MM IN DIAMETER AND THE AORTIC NECK ANGLE WAS 100 DEGREES. AFTER THE ENDURANT BIFURCATED STENT GRAFT ENBF3216C145EJ WAS DEPLOYED THERE WAS A TYPE I ENDOLEAK SEEN ON ANGIOGRAM. AN ENDURANT CUFF ENCF3232C49EJ WAS IMPLANTED; HOWEVER, THE ENDOLEAK DID NOT RESOLVE AND TOUCH-UP WAS DONE WITH A BALLOON. THE TYPE I ENDOLEAK STILL DID NOT RESOLVE. THE ENDOLEAK WAS ATTRIBUTED THE AORTIC NECK ANGLE BELOW THE RENAL ARTERY WHICH MADE THIS A DIFFICULT CASE. THE DECISION WAS MADE TO NOT FURTHER INTERVENE AS THE ENDOLEAK MAY RESOLVE ON IT'S OWN. THE PHYSICIAN WILL MONITOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16568 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01141427

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention