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

Model Number ETCF3636C49E

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

Patient Problem Injury (2348)

Event Date 05/27/2015

Event Type  malfunction  

Event Description

An endurant ii stent graft system was implanted for the endovascular treatment of a 6.1 cm diameter abdominal aortic aneurysm.It was reported that during the index procedure, after deployment of aortic cuff for treatment of a persistent type ii endoleak and placement of endovascular anchors, the physician noticed the aortic cuff looked infolded and the supra renal stents did not appear to deploy correctly.This was confirmed with intravascular ultrasound.There were no endoleaks as a result of the cuff infolding at the end of the procedure.The physician stated the event was related to the device.  no clinical sequelae were reported and the patient is being monitored.Film review analysis: review of 2 short videos during an angio intervention revealed that a talent aaa was seen positioned with an endurant aortic cuff placed approximately 1cm above the bifurcate aortic body.Several anchors were also seen placed within the aortic body and bifurcate.Ballooning was performed within the aortic body.After deflation, the ballooned stent graft did not appear to be fully apposed within the bifurcate aortic body.No contrast injections were seen in the video¿s therefore the patency of the graft lumens or any possible endoleak could not be assessed.A single still angio image without contrast showed the suprarenal stents from the endurant cuff; however, the reported suprarenal entanglement could not be confirmed (or ruled out) from this single image.The cause of the reported stent graft infolding and suprarenal stent entanglement could not be determined from the limited films provided.Images showing the deployment of the aortic cuff and removal of the cuff delivery system were not available for review.The non¿contrast images also made the assessment of the events and determination of the possible cause difficult.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

• 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: 4856866
• MDR Text Key: 16462242
• Report Number: 9612164-2015-01045
• 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: 02/04/2016

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: 07/21/2016
• Device Model Number: ETCF3636C49E
• Device Catalogue Number: ETCF3636C49E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/27/2015
• Initial Date FDA Received: 06/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/04/2016
• Date Device Manufactured: 07/22/2014
• 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 Age: 00081 YR