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

Catalog Number ETCF2828C49E

Device Problems Difficult to Remove (1528); Separation Failure (2547); Activation, Positioning or Separation Problem (2906)

Patient Problem Injury (2348)

Event Date 07/17/2014

Event Type  Injury  

Event Description

An aneurx stent graft system was implanted for the endovascular treatment of an abdominal aortic aneurysm.It was reported that there was disease progression with aortic neck dilatation.The aortic neck is 25 mm in diameter at the renal arteries and is ectatic.A recent ct revealed a proximal type i endoleak.The patient underwent a secondary procedure for the proximal type ia endoleak.An endurant aortic cuff 28x28x49 was inserted to the intended landing zone.The physician advanced the wheel release of the supra-renal stents when the aortic cuff was half way deployed.The apices were deployed deploying all at the same time and were in perfect position, during the removal the physician was attempting to accordion the aortic cuff to shorten the cuff, during that attempt the outer graft cover caught the bottom of the cuff and pushed it forward.When the accordion was attempted the stent graft was pushed up and one apex completely exverted between the fabric and the aortic wall and when the nose cone was pulled back to reseat in the graft cover it caught a different apex and inverted that apex.The physician attempted to use a balloon to correct the inverted apex however was unable to correct the apex.The physician implanted an endurant aortic cuff 25x25x49.There were no endoleak present at the end of the intervention.The patient had a ct four days post index procedure and revealed that there are no endoleaks present.The physician will monitor the patient.The physician stated, the patient is doing fine.No clinical sequelae were reported.The review of returned films 1 month post-index procedure revealed that the aneurx bifurcate was positioned several mm's below the renal arteries; the ipsilateral limb and extension were placed into the right common iliac, and the contra limb and extensions into the left common iliac.The stent graft proximal od was 18mm.The proximal neck was angulated 75 degrees (a-p).The flow divider was located near the bottom of the neck.The max diameter aaa measured 9.3cm; no endoleak was seen.The limbs were patent and essentially straight; bilaterally.Review of returned films 3 years post-implant revealed that the aneurx bifurcate was positioned approximately 5 mm's below the renal arteries.The stent graft proximal od was 22mm.The proximal neck was angulated 70 degrees (a-p).The max diameter aaa measured 9.5 cm; no endoleak was seen.The limbs were patent and essentially straight; bilaterally.Review of returned films 6 years post-implant revealed that the aneurx bifurcate was positioned approximately 15 mm's below the renal arteries, which is an increase from the 1-month post-implant images.The stent graft proximal od was 23mm.The proximal neck was angulated 80 degrees (a-p).The flow divider was located in the angulated portion of the stent graft near the bottom of the neck.The max diameter aaa measured 10.0cm; no endoleak was seen.The limbs were patent and essentially straight; bilaterally.The likely cause of the reported type i endoleak (which could not be confirmed on the films provided), and the observed migration (not reported, but observed on the films) was likely due to disease progression; neck dilatation.Images during the secondary aortic cuff implant were not provided.It is likely that the intentional stent graft shortening within the severely angulated proximal neck (off label use) contributed to the secondary events.

Event Description

Additional information received for this case.It was reported that currently the aneurysm is 11 cm to 12 cm in diameter.It was reported that the patient's stent graft has become infected.It was reported that the patient had a recent procedure to resolve type ii endoleak from the lumbar arteries.The physician used coils in the lumbar artery and glue into the aneurysm sac to resolve the type ii endoleak.It is believed the patient developed the infection due to coiling and glue procedure.The physician elected to explant the aneurx stent graft, partially explanted the endurant aortic cuff, and performed an axio-bi-fem graft.No additional clinical sequelae were reported.

Manufacturer Narrative

(b)(4).Evaluation, conclusion: off-label, unapproved, or contraindicated use (intentional stent graft shortening within an severely angulated proximal aortic neck).

Manufacturer Narrative

(b)(4).

• Brand Name: ENDURANT II
• 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: 3723052
• MDR Text Key: 4271501
• Report Number: 2953200-2014-00621
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2015
• Device Catalogue Number: ETCF2828C49E
• Device Lot Number: V04104164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2014
• Date Device Manufactured: 08/26/2013
• 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: 00065 YR