BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ILIAC

    MDR report key: 3100351 · Received May 8, 2013

    Report

    Report Number
    2953200-2013-00852
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 11, 2013
    Report Date
    May 17, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ENDOLEAK, RUPTURE. UNKNOWN CAUSE OF EVENT. CONCLUSION: UNKNOWN CAUSE OF EVENT.

    Additional Manufacturer Narrative · 1

    EVALUATION, METHODS: (FILMS).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY AND ADMITTED TO THE HOSPITAL WITH ABDOMINAL AND BACK PAIN. THE ABDOMINAL AORTIC ANEURYSM WAS RUPTURED. THE PHYSICIAN IMMEDIATELY PERFORMED AN OPEN SURGICAL REPAIR WITH THE REMOVAL OF ENDURANT STENT GRAFT. DURING THE REMOVAL OF STENT GRAFT THE PHYSICIAN OBSERVED THAT THE RIGHT LIMB WAS CROSSED OVER AND A TYPE III ENDOLEAK, FABRIC. IT WAS NOTED THAT THE DEVICE WAS PLACED SO THAT THE ILIAC LIMBS CROSSED OVER DUE TO ANGULATION AT THE DISTAL END OF THE STENT GRAFT. THERE WAS ALSO A NOTE OF A TYPE II ENDOLEAK FILLING THE ANEURYSM FROM LUMBAR ARTERIES. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    THE RETURNED DEVICES ANALYSIS HAS BEEN COMPLETED. THE DEVICE WAS EXPLANTED DURING SURGICAL CONVERSION DUE TO A RUPTURED AAA. DETAILS OF THE PATIENT¿S INITIAL TREATMENT USING AN ENDURANT STENT GRAFT SYSTEM, INCLUDING ANEURYSM MORPHOLOGY, WERE NOT PROVIDED. IT WAS REPORTED THAT THE PATIENT WAS NOTED TO HAVE AN EXPANDING AAA, WITH NO EVIDENCE OF ANY ENDOLEAK ON ULTRASOUND OR CTA. THE PATIENT RECENTLY PRESENTED WITH ABDOMINAL PAIN AT WHICH TIME CTA CONFIRMED THAT THE AAA HAD RUPTURED. ANGIOGRAPHY PRIOR TO SURGERY FOUND NO EVIDENCE OF ANY ENDOLEAK, AND THE DECISION WAS MADE TO PROCEED WITH AN EXPLORATORY LAPAROTOMY. DURING THE SURGERY AN EXTENSIVE RETROPERITONEAL HEMATOMA WAS OBSERVED, BUT THE AAA SAC WAS NOT VERY TENSE. UPON OPENING THE ANEURYSM SAC BOTH FRESH AND OLDER THROMBUS WAS OBSERVED. IT WAS REPORTED THAT WHEN THE STENT GRAFT WAS LYING IN ITS NORMAL ANATOMICAL POSITION, THERE WAS NO EVIDENCE ANY MAJOR ENDOLEAK THROUGH THE FABRIC. HOWEVER, WHEN THE RIGHT (CONTRALATERAL) LIMB WAS MOVED ANTERIORLY AND SUPERIORLY, THERE WAS A JET OF BLOOD SEEN FROM A TEAR SITUATED IN THE POSTERIOR ASPECT OF THE DISTAL MAIN BODY JUST ABOVE THE OVERLAPPING AREA OF THE CONTRALATERAL LIMB AND GATE. THE DEFECT IN THE GRAFT WAS REPORTED TO BE ABOUT 2-3 MM IN DIAMETER. ONCE THE LIMB WAS PLACED BACK INTO ITS NORMAL POSITION, THERE WAS NO EVIDENCE OF ANY BLEEDING. A PORTION OF THE CONTRALATERAL LIMB WAS EXCISED, OVERSEWN PROXIMALLY AND DISTALLY, AND A FEM-FEM BYPASS WAS PERFORMED; THE OTHER STENT GRAFT COMPONENTS WERE LEFT IN THE PATIENT. THE 6CM LENGTH SECTION OF THE EXCISED CONTRALATERAL LIMB WAS RETURNED TO MEDTRONIC. HOWEVER, THE SECTION OF THE STENT GRAFT WITH THE OBSERVED FABRIC TEAR NEAR THE ORIGIN OF THE CONTRA LIMB WAS INCORPORATED INTO THE CLOSURE AS PART OF THE REPAIR, AND THEREFORE, COULD NOT ALSO BE RETURNED FOR ANALYSIS. THE PATIENT WAS SUCCESSFULLY REPAIRED. FILMS FROM PRE-IMPLANT AND POST-IMPLANT STUDIES WERE RETURNED TO MEDTRONIC FOR REVIEW. IMAGES AT PRE-IMPLANT SHOW AN 8 CM MAX DIAMETER AAA, WHICH CONTAINED THROMBUS AND CALCIFICATION. AN AREA OF CALCIFICATION IS ALSO SEEN APPROXIMATELY 5 CM BELOW THE RENALS ON THE POSTERIOR SIDE OF THE AORTA. THE ILIACS ARE MODERATELY CALCIFIED. IMAGES JUST PRIOR TO EXPLANT SHOW THAT THE AAA HAS INCREASED TO 14 CM MAX DIAMETER. NO ENDOLEAK IS SEEN. NEAR THE LEVEL OF THE PROXIMAL GRAFT MARKERS OF THE CONTRALATERAL LIMB (NEAR THE FLOW DIVIDER) THERE IS AN AREA OF CALCIFICATION SEEN ON THE POSTERIOR WALL OF THE AORTA WHERE THE NECK TRANSITIONS TO THE AAA SAC. BOTH THE IPSILATERAL AND CONTRA LIMBS APPEAR TO BE IN DIRECT CONTACT WITH THIS CALCIFIED AREA. A PHOTOGRAPH FROM THE EXPLANT WITH THE LIMB IN THE ¿NORMAL¿ ANATOMICAL POSITION SHOW SPRINGS #6 ¿ #8 OF THE GATE EXITING THE AORTIC BODY; NO ENDOLEAK IS SEEN. WHEN THE LIMB IS LIFTED A JET OF BLOOD IS SEEN EXITING BETWEEN THE BIFURCATE AORTIC BODY (SPRING #5) AND THE ORIGIN OF THE CONTRA LIMB AT THE LEVEL OF THE FLOW DIVIDER (SPRING #6). FROM THE EXAMINATION OF THE RETURNED SECTION OF THE CONTRALATERAL LIMB AND CLINICAL INFORMATION PROVIDED, THE CAUSE OF THE OBSERVED FABRIC TEAR SEEN DURING THE OPEN REPAIR COULD NOT BE DETERMINED. A 6 CM LENGTH SECTION OF THE CONTRALATERAL LIMB, INCLUDING A 2 CM LENGTH SECTION OF THE OVERLAPPING BIFURCATE GATE, WAS EXAMINED. NO INTEGRITY ISSUES WERE SEEN FROM THIS SECTION OF THE STENT GRAFT. SINCE THE REPORTED FABRIC TEAR WAS LOCATED PROXIMAL TO THIS RETURNED SECTION OF LIMB AND OVERSEWN AS PART OF THE REPAIR, THE OBSERVED FABRIC TEAR COULD NOT BE EXAMINED. HOWEVER, AS SEEN FROM THE RETURNED FILMS AND PHOTO¿S, A POSSIBLE SOURCE OF THE FABRIC HOLE MAY HAVE BEEN ABRASION FROM A CALCIFIED AREA OF THE AORTA SEEN NEAR THE SITE OF THE REPORTED FABRIC TEAR AT THE ORIGIN OF THE LIMBS. NO ENDOLEAK WAS SEEN ON THE FILMS, BUT AS DEMONSTRATED BY THE PHYSICIAN DURING THE EXPLANT, THE HOLE MAY HAVE BEEN ¿COVERED¿ DURING THE PATIENT¿S FOLLOW-UP IMAGING WHEN THE ORIGIN OF THE CONTRALATERAL LIMB WAS IN THE NORMAL ANATOMICAL POSITION RELATIVE TO THE AORTIC BODY. IT IS CONCEIVABLE THAT THE IN-VIVO CONFIGURATION OF THE STENT GRAFT COULD CHANGE DEPENDING ON THE PATIENT¿S POSITION; IF THE LIMB WAS ORIENTATED IN A CERTAIN WAY THE HOLE COULD BECOME PATENT AND BLOOD COULD THEN BE RELEASED INTO THE SAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200895 ENDURANT ILIAC SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00456874

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention