BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3063694 · Received April 17, 2013

    Report

    Report Number
    2953200-2013-00708
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    March 22, 2013
    Report Date
    May 2, 2013
    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). EVALUATION, METHOD: FILM EVALUATION. RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); CAUSE OF EVENT IS UNKNOWN. CONCLUSION: CAUSE OF EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A FOLLOW UP ANGIOGRAM HAS BEEN DONE, NOTING AN ENDOLEAK. THE SOURCE IS LIKELY FROM LEFT HYPOGASTRIC ARTERY. THE PHYSICIAN WILL MONITOR THE PATIENT.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 45 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE RIGHT COMMON ILIAC WAS 61MM IN DIAMETER, THE LEFT INTERNAL ILIAC WAS 45MM. THE AORTIC NECK WAS 25MM IN DIAMETER AND THERE WAS 20 DEGREES OF ANGULATION. THE AORTIC BIFURCATION WAS 35 MM IN DIAMETER; RIGHT ILIAC LIMB DIAMETER WAS 16MM/61MM/47MM; LEFT ILIAC LIMB DIAMETER WAS 15MM/14MM/14MM. THE VESSELS WERE MODERATELY TORTUOUS AND MODERATELY CALCIFIED. IT WAS REPORTED THAT THE PHYSICIAN MADE THE DECISION TO LAND IN LEFT EXTERNAL ILIAC WITHOUT EMBOLIZATION OF ECTATIC INTERNAL (HYPOGASTRIC) ARTERY DUE TO; DIFFICULT ACCESS TO HYPO ORIGIN AND LENGTH OF PROCEDURE DUE TO INITIAL RIGHT FEMORAL ACCESS ISSUES. THERE WAS A TYPE IB ENDOLEAK NOTED; HOWEVER IT WAS NOT ROBUST, PHYSICIAN DETERMINED HEPARIN REVERSAL WOULD ALLOW OCCLUSION. THE RIGHT COMMON ILIAC ARTERY IS ANEURYSMAL SO THE RIGHT ILIAC LIMB WAS USED TO COVER THE RIGHT HYPOGASTRIC ARTERY. THE PHYSICIAN INTENTIONALLY COVERED BOTH HYPOGASTRIC ARTERIES THIS WAS A PLANNED APPROACH. THE PATIENT RECEIVED 7 UNITS (SOME FROM CELL SAVER) DURING THE CASE DUE TO THE ISSUES ENCOUNTERED DUR ING ACCESS TO THE RIGHT FEMORAL ARTERY. THE PHYSICIAN WILL MONITOR THE PATIENT. THE PATIENT IS FINE. A REVIEW OF RETURNED PRE-IMPLANT FILMS SHOWED A 4.5CM DIAMETER AAA; A 6CM MAX DIAMETER RIGHT COMMON ILIAC ANEURYSM, AND A 4.8CM MAX DIAMETER LEFT INTERNAL ILIAC ANEURYSM. BOTH ILIAC ARTERIES, ESPECIALLY THE RIGHT, WERE SEVERELY TORTUOUS. A SINGLE VIDEO IMAGE DURING THE IMPLANT SHOWS THAT THE BOTH LIMBS WERE EXTENDED INTO THE EXTERNAL ILIAC ARTERIES; THE LEFT ILIAC LIMB EXTENDED 1-2 CM BEYOND THE INTERNAL ILIAC ARTERY ORIGIN. A CONTRAST INJECTION INTO THE LEFT LIMB SHOW CONTRAST FILLING THE NON-EMBOLIZED LEFT INTERNAL ILIAC ANEURYSM, LIKELY FROM A DISTAL TYPE I OR TYPE IV ENDOLEAK. THE CAUSE OF THE ENDOLEAK FROM THIS SINGLE IMAGE IS UNKNOWN; MAY BE DUE TO INSUFFICIENT DISTAL SEALING. POST-IMPLANT CTA'S WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165431 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01701781

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR