BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2397911 · Received January 4, 2012

    Report

    Report Number
    2953200-2012-00008
    Event Type
    Injury
    Date Received
    January 4, 2012
    Date of Event
    December 7, 2011
    Report Date
    December 7, 2011
    Manufacturer
    MEDTRONIC, GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK) - PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (SHORT AND CONICAL NECK). EVALUATION, CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (SHORT AND CONICAL NECK MAY).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.5 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE VESSEL MORPHOLOGY AT THE TIME OF THE INITIAL SIZING THE AORTIC NECK WAS 12 MM LONG AND IT MEASURED 20 MM IN DIAMETER PROXIMALLY AND 26 MM IN DIAMETER DISTALLY. THE AORTIC NECK HAD 25 DEGREE CRANIAL ANGULATION AND 19 DEGREE LAO ANGULATION. THE ILIAC ARTERIES WERE NORMAL. IT WAS REPORTED THAT AFTER THE STENT GRAFT WAS IMPLANTED THERE WAS A SLIGHT PROXIMAL TYPE 1 ENDOLEAK. THE LOCATION OF THE ENDOLEAK WAS BALLOON WITH A RELIANT BALLOON AND A Z-MED BALLOON, BUT DID NOT RESOLVE THE ENDOLEAK. A 10 X 50 PALMAZ STENT WAS IMPLANTED OVER A 25 MM Z-MED BALLOON. THE ENDOLEAK IMPROVED BUT DID NOT COMPLETELY RESOLVE. THE DECISION WAS MADE TO NOT FURTHER INTERVENE. THE PHYSICIAN WILL MONITOR THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC, GALWAY V00950089

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention