BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2141162 · Received June 22, 2011

    Report

    Report Number
    2953200-2011-01172
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    May 24, 2011
    Report Date
    October 22, 2021
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (ENDOLEAK, STENT GRAFT MISPLACEMENT, SURGICAL CONVERSION), (UNK CAUSE OF EVENT; PENDING EXPLANT EVAL), (USER DID NOT CONFIRM WHETHER ALL THE SUPRARENAL STRUTS HAD COMPLETELY FLARED OUT DURING DEPLOYMENT). EVAL, CONCLUSION: (UNK CAUSE OF EVENT; PENDING EXPLANT EVAL), (USER DID NOT CONFIRM WHETHER ALL THE SUPRARENAL STRUTS HAD COMPLETELY FLARED OUT DURING DEPLOYMENT).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 6 CM ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 24 - 25 MM IN DIAMETER ALONG ITS LENGTH WITH MILD ANGULATION BUT WITHOUT CALCIFICATION OR THROMBUS. ILIAC VESSELS HAD UNREMARKABLE TORTUOSITY AND CALCIFICATION. IT WAS REPORTED THAT THE ENDURANT BIFURCATED STENT GRAFT WAS DEPLOYED WITHOUT ISSUES; HOWEVER, IT WAS NOT CONFIRMED WHETHER ALL THE SUPRARENAL STRUTS HAD COMPLETELY FLARED OUT DURING DEPLOYMENT. THE DELIVERY SYSTEM WAS TORQUED AND ADVANCED FORWARD DURING THE DEVIC REMOVAL AS NORMAL. AS NO RESISTANCE WAS FELT DURING THE DEVICE REMOVAL, THE PHYSICIAN CONTINUED TO PULL DOWNWARD ON THE DELIVERY SYSTEM. THE ANGIOGRAM THEN SHOWED THAT TWO OF THE SUPRARENAL STRUTS WERE CROSSED AND THAT THE FRONT OF THE GRAFT FABRIC HAD MOVED DOWN SLIGHTLY, RESULTING IN A SLIGHT PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN BALLOONED THAT AREA; HOWEVER, THERE WAS STILL A SLIGHT PROXIMAL TYPE I ENDOLEAK. NO FURTHER INTERVENTION WAS PERFORMED AT THE TIME OF THE IMPLANT. THEN, APPROX 1 WEEK POST-IMPLANTATION, THE PHYSICIAN ELECTED TO SURGICALLY-CONVERT THE PT TO AN OPEN REPAIR. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE. THE EXPLANTED GRAFTS HAVE BEEN RECEIVED BY MEDTRONIC, AND THE EVAL IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00870172

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention