BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II STENT GRAFT SYSTEM

    MDR report key: 2842936 · Received November 21, 2012

    Report

    Report Number
    2953200-2012-02256
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 28, 2012
    Report Date
    October 28, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK, VESSEL OCCLUSION); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-OPERATIVELY RUPTURED ANEURYSM); INCORRECT TECHNIQUE/PROCEDURE (STENT GRAFT WAS USED FOR TREATMENT OF A PATIENT WITH A PRE-OPERATIVELY RUPTURED ANEURYSM). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PRE-OPERATIVELY RUPTURED ANEURYSM); OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (STENT GRAFT WAS USED FOR TREATMENT OF A PATIENT WITH A PRE-OPERATIVELY RUPTURED ANEURYSM).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 9.5 CM DIAMETER PRE-OPERATIVELY RUPTURED ABDOMINAL AORTIC ANEURYSM APPROXIMATELY THREE WEEKS AGO. THE LEFT RENAL ARTERY WAS SEVERELY STENOSED. IT WAS REPORTED THAT DURING THE DEPLOYMENT OF THE ENDURANT BIFURCATED STENT GRAFT ((B)(4)), IT DID NOT LAND AT THE INTENDED LANDING ZONE AND THERE WAS A PROXIMAL TYPE I ENDOLEAK. THE ENDOLEAK WAS FIXED WITH AN ENDURANT AORTIC CUFF ((B)(4)). THE FINAL ANGIOGRAM SHOWED THERE WAS A SMALL PROXIMAL TYPE I ENDOLEAK AND THE LEFT RENAL ARTERY AND HAD LIMITED FLOW. THERE WAS AN ACCESSORY LEFT RENAL ARTERY PROVIDING FLOW TO THE LEFT KIDNEY. IT WAS DECIDED THAT AFTER A BRIEF ATTEMPT TO CANNULATE THE LEFT RENAL AND POTENTIALLY PUT IN ANOTHER STENT GRAFT HOWEVER, THE PHYSICIAN DECIDED TO JUST MONITOR THE PATIENT AS THERE WAS EFFICIENT BLOOD FLOW GOING TO THE LEFT KIDNEY. THE PHYSICIAN BELIEVES THE PROXIMAL TYPE I ENDOLEAK WILL RESOLVE AFTER 30 DAYS. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT II STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01705074

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention