MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT II EXTENSION CUFF; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number ETCF3636C49E

Device Problems Difficult to Remove (1528); Separation Failure (2547)

Patient Problem Injury (2348)

Event Date 03/16/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Conclusion: off-label, unapproved, or contraindicated use (aortic neck angulation).

Event Description

A talent aaa stent graft system was implanted in patient for endovascular treatment of a 7.6 cm diameter abdominal aortic aneurysm.The proximal aortic neck measured 20 mm in diameter and 19 mm in length at the time of implant.The proximal aortic neck expanded to 30 mm in diameter and 20 mm in length currently.The aortic neck angle measured 70 degrees and remained the same to date.The vessel was severely tortuous and mildly calcified.It was reported that five months ago a ct aneurysm revealed that there was aneurysm enlargement.A recent angiogram revealed a proximal type i endoleak.The endurant aortic cuff was deployed without issues and appeared to oppose to the aortic wall.When the physician attempted to retrieve the delivery system, the suprarenal stent appeared to be stuck within the nose cone assembly.The delivery system was maneuvered several times but the suprarenal stent remains stuck.It was seen on the fluoroscopy that the proximal end of the stent graft had been pulled off the patient's left aortic wall at the level of the left renal artery.The patient was converted to open repair because the other access artery was not able to be accessed due to severe tortuosity.The proximal portion of the bifurcate stent graft and part of the bifurcate limbs were explanted.The endurant aortic cuff was removed from the patient.An aorta-bi-fem graft was sewn onto the aorta with the right limb being tunneled through the existing bifurcate stent graft limb and the left limb being bypassed to the femoral artery.The event was resolved.The physician evaluated the endurant aortic cuff after it was explanted, and it was revealed the suprarenal stent apices were entangled resulting in the inability to remove the delivery system from the patient.The physician assessed that the proximal type i endoleak and aneurysm enlargement was due to disease progression.No additional clinical sequelae was reported and the patient is fine.

Manufacturer Narrative

The devices were explanted during surgical conversion after an unsuccessful evar intervention for a proximal type i endoleak caused by neck dilatation.The patient was originally treated for an 8 cm infrarenal abdominal aortic aneurysm using a talent stent graft system.Serial follow-up's for the first three years demonstrated decreasing sac size and no endoleak.Cta in early 2013 revealed a slight increase in the residual sac size with no endoleak.Due to the patient's renal insufficiency, follow-up thereafter with non-contrast ct scans and abdominal ultrasound demonstrated progressive increasing aaa diameter, but again no endoleak.The most recent ultrasound revealed a aaa diameter of 6.7 cm, and during a review of the non-contrast ct scan in (b)(6) 2015 dilatation of the aneurysm neck was noted.The decision was made to implant an aortic cuff with limited contrast use.Aortogram confirmed the suspected type i proximal endoleak, and also demonstrated marked tortuosity of the aorta as well as the tortuous left iliac artery.From the right side the endurant ii 36mm aortic cuff was positioned.However, during deployment the suprarenal struts did not properly release; this was attributed to the marked tortuosity of the aorta.Two of the suprarenal stents appeared crossed and became caught in the delivery system, and all maneuvers to correct this problem failed.Attempts at left-sided access with balloon inflation to try to correct the stuck delivery system could not be performed due to the tortuous left iliac anatomy, and the decision was made to convert the patient during open repair and explant the stent grafts.During the explant the proximal section of the bifurcate, the aortic cuff, and the trapped delivery system were all removed from the patient.The patient was successfully converted using a hemashield 14 x 7 mm bifurcation graft.From the examination of the returned devices and clinical information provided, the exact cause of the proximal type i endoleak could not be determined.However, it appears likely that disease progression likely led to the stent graft migration, endoleak, and aneurysm expansion.Review of films between 19 - 63 months implant duration confirmed that the stent graft migrated distally approximately 2cm, with increasing proximal neck diameter and stent graft angulation, increasing aaa diameter, and no observation of any endoleak.The device was returned with the bifurcate transected distally near the level of the flow divider.The transected contra stub and the 1st stent of both the ipsilateral and contra limb were also returned.The majority of the stent graft limbs were not returned; reported as left in the patient.The bifurcate was returned with one of the bare springs forcibly inverted outward 180°; this bare spring flip (not seen on the films in-vivo) most likely occurred during attempts to remove the caught aortic cuff delivery system or during the open repair procedure.On the distal end of the bifurcate first covered spring, 2 cm below the proximal graft margin, a 2.9 mm length x 0.3 mm wide abrasion tear caused by the underlying stent was observed.It is possible that this tear may have contributed to the aneurysm expansion; however, no endoleak was noted in this location prior to explant.Three smaller abrasion and crease fatigue related holes (0.3 - 0.7 mm in length) were also observed along the bifurcate aortic body, but appeared covered by tissue/thrombus in the "as received" condition and likely were not an endoleak source.Other than several fabric punctures, and multiple cuts <(>&<)> burn holes likely occurring during explant, no other integrity issues were also observed on any of the stent graft components.The exact cause of the proximal cuff suprarenal stent entanglement, leading to the inability to remove the cuff delivery system and surgical conversion, could not be determined from the information provided.The intact aortic cuff was returned detached from the bifurcate; no device integrity issues were observed with the endurant cuff.No suprarenal stent entanglement was observed.It is possible that improper release of the suprarenal stents was due to implanting within the angulated stent graft and angulated proximal neck.Per review of the device history record, the devices were verified to have met all talent and endurant manufacturing specifications and quality inspections prior to shipment.This includes dimensional verification, packaging, delivery system inspection, and stent graft inspection.The endurant aortic cuff delivery system was also returned.Upon inspection of the device, there was major twisting in the graft cover noted.The tapered tip was damaged and compressed.The external slider was rotated and the graft cover retracted accordingly.Similarly, the blue wheel was rotated and the tapered tip lumen advanced accordingly.The spindle tube appeared to have no damage.A potential root cause could not be determined during analysis.A detailed analysis of the returned aortic cuff delivery system is covered in a separate report.Review of pre-implant cta's confirmed that the patient had a 7.5cm x 6.6cm max diameter aaa.The approximate neck diameter at the level of the lowest left renal artery measured 21mm, and 1cm lower was 24mm.The neck contained areas of thrombus and calcification.The infrarenal neck was angulated 65deg r-l, and the suprarenal angulation was 60 deg l-r.The distal aaa sac contained thrombus; 2.5cm flow lumen.The distal aortic diameter was 15mm and extensively calcified.The iliac arteries were mildly tortuous and very calcified.The right common iliac artery diameter ranged from 10 - 11mm , and the left common iliac artery diameter ranged from 11 - 12mm.Review of cta's 19 months post-implant revealed that a talent stent graft system had been implanted.The bifurcate was positioned approximately 5mm below the renals within the angulated neck.The stent graft proximal od measured 27mm.The bifurcate aortic body was angulated 35deg r-l and 60 deg a-p; relative to the iliac limbs.The ipsi limb was placed from the left side and was extended with an aneurx limb into the left common iliac artery.The contra limb and extension were placed into the right common iliac artery.Both limbs were patent.The max diameter aaa was 5.6 x 4.5cm.No endoleak or any stent graft issues were observed.Review of cta's from 3+ years post-implant ((b)(6) 2013) revealed that the bifurcate was now approximately 2cm below the renals; the bifurcate has migrated distally approximately 15mm from the previous study in 2011.The proximal stent graft od is currently 29mm.The bifurcate aortic body was angulated 55deg r-l and 75 deg a-p; relative to the iliac limbs (increasing <(><<)>).The max diameter aaa is 6.1 x 4.9cm, slightly larger from the previous study, and no clear endoleak was seen.Both limbs were patent and no stent graft issues were observed.Review of cta's from 5+ years post-implant revealed that the bifurcate is now approximately 2.5cm below the renals.The films were non-contrast; therefore measurements were approximate, and stent graft patency and any endoleak could not be assessed.The proximal stent graft od is currently 29mm.The bifurcate aortic body is angulated 60deg r-l; relative to the iliac limbs.The max diameter aaa is 6.4 x 5.3cm, slightly larger from the previous study.No other stent graft issues were observed.A single still angio image during an intervention revealed that the aortic body was angulated approximately 70deg r-l relative to the left/ipsi limb.An acute 90deg bend was observed at the origin of the ipsi limb.Both limbs were patent and a likely proximal type i endoleak was seen.The angio injection was near the bifurcate proximal stent graft margin, and the renals were not clearly visible in the films.No other stent graft issues were seen.Another image without contrast showed that an endurant cuff was implanted; placed approximately 2cm above the bifurcate.The spindle was observed not recaptured into the sleeve, and was at the level of the suprarenal stents which may have been entangled.The tapered tip was 1cm above the spindle.One or more of the suprarenal stents may have been caught in the spindle or tip.Lack of contrast did not permit assessment of any endoleak.The exact cause of the proximal type i endoleak could not be determined.However, it appears likely that disease progression, with neck dilatation and angulation, likely led to the stent graft migration and endoleak.From the limited images provided during the aortic cuff intervention the cause of the malposition of the cuff, suprarenal stent entanglement, and delivery system removal difficulties could not be determined.This may have been due to implanting within the angulated stent graft and angulated proximal neck.

Manufacturer Narrative

Corrected information: no eval explain code.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II EXTENSION CUFF
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: eric elliott ; 3576 unocal place; santa rosa, CA 95403 ; 7075912586
• MDR Report Key: 5056904
• MDR Text Key: 25028438
• Report Number: 2953200-2015-01493
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2017
• Device Model Number: ETCF3636C49E
• Device Catalogue Number: ETCF3636C49E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2015
• Supplement Dates Manufacturer Received: 09/16/2015
• Supplement Dates FDA Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/07/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 00071 YR