BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1993810 · Received February 11, 2011

    Report

    Report Number
    2953200-2011-00380
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (ENDOLEAK), (AORTIC NECK WAS 19 MM IN DIAMETER, 36 MM IN LENGTH, AND ANGULATED 88 DEGREES WITH MILD CALCIUM. EVAL, CONCLUSION: (AORTIC NECK WAS 19 MM IN DIAMETER, 36 MM IN LENGTH, AND ANGULATED 88 DEGREES WITH MILD CALCIUM.

    Description of Event or Problem · 1

    AN ENDURANT BIFURCATED STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 6.7 MM DIAMETER ABDOMINAL AORTIC ANEURYSM APPROX ONE MONTH AGO. VESSEL MORPHOLOGY WAS REPORTED AS THE PROXIMAL AORTIC NECK WAS 19 MM IN DIAMETER, 36 MM IN LENGTH, AND ANGULATED 88 DEGREES WITH MILD CALCIUM. THE RIGHT COMMON ILIAC WAS 9 TO 10 MM IN DIAMETER; LEFT COMMON ILIAC WAS 7-10-7 MM IN DIAMETER. ACCESS VESSELS WERE SMALL AND CALCIFIED; RIGHT EXTERNAL ILIAC WAS 6 MM IN DIAMETER, LEFT EXTERNAL ILIAC WAS 5.4 MM IN DIAMETER. IT WAS REPORTED THAT AN (B)(4) WAS UNABLE TO BE ADVANCED THROUGH THE VESSELS (REF MFR# 2953200-2011-00377). THE PHYSICIAN ROTATED THE DELIVERY SYSTEM SLIGHTLY COUNTER CLOCKWISE DURING THE ADVANCEMENT TO IMPROVE PUSHABILITY, BUT THE GRAFT COVER SHEARED AND EXPOSED THE STENT GRAFT. THE DEVICE WAS REMOVED FROM THE PT. THE PHYSICIAN USED SEQUENTIAL DILATORS, AND THEN ADVANCED AN (B)(4) (REF MFR# 2953200-2011-00378) ON THE RIGHT SIDE WITHOUT DIFFICULTY. THE CONTRALATERAL LIMB (B)(4) (REF MFR# 2953200-2011-00379), A CONTRALATERAL EXTENSION (B)(4) , AND AN IPSILATERAL EXTENSION (B)(4) (REF MFR# 2953200-2011-00381) WERE ALL PLACED WITHOUT DIFFICULTIES. THE FINAL ANGIOGRAM SHOWED A SIGNIFICANT UNK ENDOLEAK THAT WAS DIFFICULT TO DIAGNOSE. THE PHYSICIAN BELIEVES THAT THERE MAY BE AN ENDOLEAK COMING FROM THE CONTRALATERAL LIMB. THE PHYSICIAN DECIDED TO RELINE BOTH ILIAC LIMBS, A (B)(4) LIMB WAS PLACED ON THE LEFT, AND A (B)(4) LIMB WAS PLACED ON THE RIGHT, BUT THE REPEAT ANGIOGRAM SHOWED NO RESOLUTION OF THE ENDOLEAK. THE PROXIMAL AORTIC NECK WAS RE-BALLOONED WITHOUT ENDOLEAK RESOLUTION. A PALMAZ STENT WAS PLACED PROXIMALLY, BUT ANOTHER ANGIOGRAM WAS NOT PERFORMED, AS THE PT HAD 300 CC OF CONTRAST ALREADY. A POST-OPERATIVE CT SCAN SHOWED THAT THE ENDOLEAK RESOLVED. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00548240

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention