BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II ILIAC STENT GRAFT

    MDR report key: 7177773 · Received January 10, 2018

    Report

    Report Number
    2953200-2018-00058
    Event Type
    Malfunction
    Date Received
    January 10, 2018
    Date of Event
    December 13, 2017
    Report Date
    March 16, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FILMS SUMMARY REVIEW: THE CAUSE AND SOURCE OF THE ENDOLEAK SEEN 7 WEEKS POST-IMPLANT COULD NOT BE DETERMINED FROM THE FILMS PROVIDED. WITHIN THE RIIA, A SMALL CONTAINED AREA OF CONTRAST, APPEARING AS A ¿VESSEL¿, WAS SEEN COURSING FROM THE RIIA EMBOLIZATION COILS TO THE RIGHT LIMBS WHERE THE RCIA WAS AT ITS MAXIMUM DIAMETER (~26MM) NEAR THE DISTAL END OF THE BIFURCATE LIMB. THE SOURCE OF THIS ENDOLEAK COULD NOT BE DETERMINED, AND IT IS UNCLEAR IF THE CONTRAST WAS FLOWING INTO OR FROM THE RIGHT LIMB(S). A TYPE III FABRIC OR A TYPE II ENDOLEAK CANNOT BE RULED OUT, AND THIS APPEARS LESS LIKELY TO HAVE BEEN A TYPE IV AFTER A 7 WEEK IMPLANT DURATION. NEAR THE LEVEL OF THE FLOW DIVIDER A SMALL LOCALIZED AREA OF CONTRAST WAS ALSO SEEN ON THE POSTERIOR OF THE AORTA FROM A LIKELY TYPE II ENDOLEAK.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT A FOLLOW UP CT WAS CARRIED OUT. A SMALL AMOUNT OF CONTRAST WAS VISIBLY LEAKING OUT FROM THE FABRIC. THE PHYSICIAN IS REPORTEDLY CONSIDERING WHETHER A TYPE IV LEAK COULD SHOW AFTER THE PROCEDURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    FILMS REVIEW SUMMARY: TWO (2) SHORT 10 SECOND LOW RESOLUTION (GRAINY) VIDEOS OF AN ANGIOGRAM DURING IMPLANT WERE RETURNED. THE BIFURCATE IPSILATERAL LIMB ON THE RIGHT SIDE HAD BEEN EXTENDED WITH ANOTHER LIMB INTO THE RIGHT EXTERNAL ILIAC ARTERY, BYPASSING THE RIGHT INTERNAL WHICH HAD BEEN COILED. CONTRAST INJECTION FROM JUST ABOVE THE LEVEL OF THE FLOW DIVIDER REVEALED CONTRAST BLUSH WHICH APPEARED TO BE COMING FROM JUST DISTAL TO THE JUNCTION BETWEEN THE BIFURCATE DISTAL IPSI LIMB AND RIGHT LIMB EXTENSION; THE CONTRAST WAS FILLING THE ANEURYSMAL RIGHT INTERNAL ILIAC ARTERY LOCATED BETWEEN THE STENT GRAFT AND EMBOLIZATION COILS. THE NEXT SHORT VIDEO REVEALED THAT AFTER IMPLANTING A LIMB ACROSS THE RIGHT LIMB JUNCTION WHERE THE ENDOLEAK WAS NOTED, AND THE PREVIOUSLY SEEN ENDOLEAK WAS STILL PRESENT AND SHOWED SIMILAR STRENGTH. THE EXACT CAUSE OF THE ENDOLEAK SEEN DURING THE PROCEDURE COULD NOT BE DETERMINED FROM THE LIMITED FILMS PROVIDED. CT¿S PRIOR TO IMPLANT WERE NOT PROVIDED AND A COMPLETE ASSESSMENT OF THE PRE-IMPLANT ANATOMY COULD NOT BE PERFORMED. NO ENDOLEAK INTERROGATION (INJECTING FROM DIFFERENT LEVELS WITHIN THE STENT GRAFT) TO HELP DETERMINE THE SOURCE AND RULE OUT OTHER ENDOLEAK SOURCES WAS SEEN. ONLY A SINGLE IMAGING VIEW POINT (A-P) WAS OBSERVED IN THE FILMS PROVIDED; THEREBY, MAKING DETERMINATION OF THE ENDOLEAK DIFFICULT. ALTHOUGH A TYPE III FABRIC ENDOLEAK CANNOT BE RULED OUT, THIS APPEARS MORE LIKELY TO HAVE BEEN AN ACUTE TYPE IV ENDOLEAK CAUSED BY FABRIC POROSITY. OTHER FACTORS SUCH AS HEPARIN DOSE, OUTFLOW RESISTANCE, IMAGING QUALITY, AND VOLUME OF THE ANEURYSM SAC MAY HAVE ALSO CONTRIBUTED TO THIS POTENTIAL TYPE IV ENDOLEAK. PENDING PLANNED 30-DAY FOLLOW-UP TO VERIFY IF THE ENDOLEAK SELF-RESOLVED; THEREBY LIKELY CONFIRMING THE TYPE IV ENDOLEAK. ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS RECEIVED FOR THIS CASE- AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 4CM DIAMETER ANEURYSM OF THE RIGHT HYPOGASTRIC ARTERY. THERE WAS NO ANEURYSM PRESENT IN THE AORTA AND THE PHYSICIAN ELECTED TO IMPLANT A BIFURCATED SYSTEM BECAUSE THERE WAS NOT ENOUGH LANDING ZONE AVAILABLE AND DUE TO AORTIC ELASTICITY. POST IMPLANTATION FLUOROSCOPY REVEALED WHAT APPEARED TO BE A TYPE III ENDOLEAK DUE TO THE CONTRAST ENTERING EARLY IN THE HYPOGASTRIC ANEURYSM SAC, HOWEVER THE PRESENCE OF THE TYPE III ENDOLEAK IN THE BIFURCATE CANNOT BE OUT RULED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE, A BIFURCATED SYSTEM WAS IMPLANTED USING ONE LIMB TO EXTEND THE IPSILATERAL AXIS AND ANOTHER TO EXTEND THE CONTRALATERAL LIMB. PREVIOUSLY THE RIGHT HYPOGASTRIC WAS EMBOLIZED. ON INJECTION OF THE FINAL CONTRAST A ENDOLEAK WAS SEEN AT THE LEVEL WHERE IPSILATERAL LIMB OF THE BIFURCATED AND THE EXTENSION WERE OVERLAPPING. BALLOONING WAS ATTEMPTED BUT UNSUCCESSFUL. THE PHYSICIAN SUSPECTED A TYPE III FABRIC TEAR AND DECIDED TO IMPLANT A SECOND LIMB IN THE RIGHT AXIS WHERE THE ENDOLEAK OBSERVED, HOWEVER THE ENDOLEAK WAS STILL PRESENT. THE PHYSICIAN DECIDED TO END THE PROCEDURE. A SCAN PERFORMED THE NEXT DAY YIELDED NO DEFINITIVE RESULTS. THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21362 ENDURANT II ILIAC STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ETLW1613C93EE

    Patients

    Seq Age Sex Outcome Treatment
    1