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

Catalog Number ETBF3616C166E

Device Problems Separation Failure (2547); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2014

Event Type  malfunction  

Event Description

Review of returned cta¿s from 1-month post-implant revealed that the bifurcate was positioned approximately 5-10mm below the renals.The neck was long and essentially straight.Beginning at the proximal graft margin, the bifurcate appears to have infolded on the left side; the infolding extends distally to the flow divider.There is possible stent graft entanglement and a proximal type i endoleak is visible.The approximate proximal neck flow lumen diameter was 28mm at the upper right renal artery near the level of the suprarenal stents; there is incomplete stent apposition to the posterior aortic wall.The stent graft od is 21x22mm at the level of the lowest left renal (where the infolding begins), 1cm lower measures 26x27mm, and 2cm lower is 27x31mm.The amount of radial infolding at this location is 19mm.Near the level of the flow divider approximately 4.5cm below the left renal, the aortic diameter narrows down to 27 x 28mm and the ipsi limb is compressed down to 6mm id.The max diameter aaa is 4.3cm and both limbs are patent.A slight amount of thrombus is seen within the ipsi limb beginning just below the flow divider extending distally into the distal aaa sac, where the ipsi limb id varies from 11-14mm.No thrombus is seen in the contra limb.The distal aortic diameter is 23x28mm.The ipsi limb is placed down into the left common iliac artery and the contra limb into the right common iliac.A dissection is seen beginning just distal to the end of the right contra limb near the iliac bifurcation.The cause of the infolding is uncertain; films prior to implant and during the implant procedure were not available for return.However, the device may have been oversized and possibly occurred due to placement of the 36mm bifurcate within the long and relatively narrow proximal neck.This infolding most likely occurred during implant, and also likely caused the entanglement of the suprarenal stents which then led to the proximal type i endoleak.The cause of the thrombus seen in the ipsi limb may be related to possible flow disturbance from the infolding and exacerbated by the stent graft compression seen near the flow divider due to the narrow neck.The cause of the right iliac artery dissection could not be determined; this may have been procedure related.

Event Description

An endurant stent graft system unknown limb extension was implanted for the endovascular treatment of a 5.0 cm diameter abdominal aortic aneurysm.It was noted that the supernal aorta was dilated at 29-30mm, and the infrarenal aorta was 26mm, then it flared back out to 28-32mm.The length of the proximal neck was 50mm and there was mild angulation at implant.It was noted that there was no tortuosity or calcification.It was reported that the 30 day post-operative scan showed that the main body is folded on itself resulting in a type i endoleak.The supra renal stent appears to be entangled with itself.During the procedure the case took place without any issues.Deployment appeared successful and nose cone retraction was uneventful.Everything appeared seamless.The graft did land about 3mm low distal to lowest renal.The aorta was straight but the supra renal aorta was dilated at 29-30mm in diameter and the infra renal aorta was 26mm for a couple mm and then flared to 28-32mm in diameter over 50mm (it looked like an hour glass).The only thing that was noticed intraoperatively was that when the infra renal graft was molded it caused the supra renal stent to draw in a little but it didn't look entangled.The supra renal stent appeared to draw in as a result of being constrained in the 26mm diameter portion of the infra renal aorta, but everything looked good on fluoroscopy and there was no type i endoleak.During the final angiogram it was noticed some hazing filling down one side of the main body and into the iliac.After the endoleak was seen on the 30 day scan it was thought that the folding occurred intraoperatively and probably upon deployment.The physician stated that it was related to the device.It was further reported that a dissection occurred distal to the right contralateral limb.It was thought that it was due to balloon molding the limb.It is not flow disrupting but is an ante grade dissection.The issue had not resolved and the patient will be monitored.No clinical sequelae were reported and the patient is fine.Additional information received reported that the physician believed that the cause of the infolding, suprarenal stent entanglement, and type ia leak was that the graft must have deployed incorrectly or maybe was packed incorrectly.It was noted that the aorta was straight and this was a straight forward case with no neck angulation.It was further noted that there was no deployment issues and nothing odd was seen on intraoperative fluoroscopy.The suprarenal stents reportedly drew in ¿a tad¿ when ballooning so the physician did not over balloon and just did ¿a light touch up.¿ the physician believed the cause of the dissection was due to the ballooning in the contra lateral limb.It was noted that this was an ante grade dissection and not a retrograde dissection.The physician reportedly did not know why the stent graft landed 3mm low.Review of cta¿s from 1-month post-implant revealed that the bifurcate was currently positioned approximately 5-10mm below the renals.The neck was long and essentially straight.Beginning at the proximal graft margin, the bifurcate appears to have infolded on the left side; the infolding extends distally to the flow divider.There is possible stent graft entanglement and a proximal type i endoleak is also visible.The proximal neck diameter is approximately 28mm at the upper right renal artery; near the level of the suprarenal stents.The stent graft outer diameter is approximately 21x22mm at the lowest left renal, (where the infolding begins), 10mm lower measures 26x27mm, and 2cm lower is 27x31mm.The amount of radial infolding at this location is 19mm.Near the level of the flow divider approx.4.5cm below the left renal, the aortic diameter narrows down to 27 x 28mm and the ipsi limb is slightly compressed down to 9mm inner diameter.The max diameter aaa is 4.3cm and both limbs are patent; however, a slight amount of thrombus is seen within the ipsi limb beginning just below the flow divider extending distally into the distal aaa sac, with the ipsi limb id varying from 11-14mm.No thrombus is seen in the contra limb.The distal aortic diameter is 23x28mm.The ipsi limb is placed down into the left common iliac artery, and the contra limb into the right common iliac.A dissection is seen beginning just distal to the end of the right contra limb near the iliac bifurcation.The cause of the infolding is uncertain; films prior to implant and during the implant procedure were not available for return.However, it is likely that placement of the 36mm bifurcate within the long and relatively narrow proximal neck may have contributed.This infolding most likely occurred during implant, and also likely caused the entanglement of the suprarenal stents which then led to the proximal type i endoleak.The cause of the thrombus seen in the ipsi limb may be related to the infolding and the stent graft compression seen in the neck.The cause of the right iliac artery dissection could not be determined; this may have been procedure related.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received for this case.It was reported that the physician explanted the stent graft due to the previously reported complications.The intervention went well with no complications.No additional clinical sequelae were reported and the patient is fine.

• Brand Name: ENDURANT
• 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: 4502749
• MDR Text Key: 5526924
• Report Number: 2953200-2015-00244
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/29/2015

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: 10/19/2016
• Device Catalogue Number: ETBF3616C166E
• Device Lot Number: V05953615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 02/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/27/2015
• Date Device Manufactured: 10/21/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 00057 YR