BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 4221189 · Received November 3, 2014

    Report

    Report Number
    2953200-2014-02273
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 23, 2014
    Report Date
    July 7, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 6.7CM DIAMETER ABDOMINAL AORTIC ANEURYSM. CURRENTLY, THE PROXIMAL AORTIC NECK MEASURE 19MM IN DIAMETER AND IS ANGULATED 35 DEGREES. IT WAS REPORTED THAT ON A ROUTINE FOLLOW UP CT SCAN, IT WAS OBSERVED THAT THE BIFURCATE HAD MIGRATED. A PROXIMAL TYPE I ENDOLEAK WAS PRESENT. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS DUE TO DISEASE PROGRESSION. AN INTERVENTION WAS PERFORMED AND AN ENDURANT AUI LIMB AND TALENT OCCLUDER WERE IMPLANTED HOWEVER, A PROXIMAL TYPE I ENDOLEAK REMAINED. THE PHYSICIAN CHOOSE TO TREAT THE PROXIMAL TYPE I ENDOLEAK WITH AN APTUS DEVICE HOWEVER, THE TYPE I ENDOLEAK DID NOT RESOLVE. THE PHYSICIAN STATED THAT THE ENDOLEAK WOULD THROMBUS OFF AND NO FURTHER TREATMENT WOULD BE PLANNED AND NO FURTHER IMAGING IS SCHEDULED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. PER THE PHYSICIAN, THE CAUSE OF THE PROXIMAL TYPE I ENDOLEAK WAS DUE TO DISEASE PROGRESSION

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. AN INTERVENTION WAS PERFORMED AND ANOTHER MANUFACTURER'S STENT GRAFT WAS IMPLANTED; HOWEVER, THE ENDOLEAK DID NOT RESOLVE. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT AND CONSULT WITH A RADIOLOGIST FOR FURTHER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702720 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04247987

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Required Intervention