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

Catalog Number ETBF2813C145EJ

Device Problems Difficult to Remove (1528); Separation Failure (2547); Malposition of Device (2616); Folded (2630)

Patient Problem Injury (2348)

Event Date 08/25/2014

Event Type  malfunction  

Event Description

An endurant stent graft system was implanted for the endovascular treatment of a 49mm in diameter abdominal aortic aneurysm.The proximal neck was 19-20 mm in diameter and 12 mm in length.The left common iliac artery was 17 mm in diameter and the right common iliac artery was 10 mm in diameter.The right external iliac artery measured 7-9-8 mm in diameter and the left external iliac artery measured 8-7 mm in diameter it was reported that after implant of the bifurcate, the delivery system was attempted to be removed however, the nose cone caught a proximal bare spring when using downward force.The tapered tip caught the point between the stent and graft and dragged it toward distal direction.As a result, the stent graft fell inward.The delivery system was able to be removed from the patient.The physician tried repair the infolding by dilating with a balloon however, the stent graft did not go back to the original position completely.It appeared that two bare springs seemed to be entangled at proximal side of the stent graft.Another manufacturer¿s excluder (gore) was used for the contralateral limb and extension of ipsilateral limb to carry out external iliac artery landing.The final angiogram showed no evidence of an endoleak so additional treatment was not performed and the procedure was completed.It is unknown if the delivery system was biased to one side prior to release of the capture mechanism.No clinical sequelae were reported and the patient is being monitored.Film review analysis: review of several still angio image confirmed that several of the suprarenal stents have been pulled down below the level of the proximal graft margin, and that 2 or more of the stents may be entangled with each other.Images during removal of the delivery system were not provided.The cause could not be determined from the images provided.Although the neck is straight l-r, the neck angulation in a-p is unknown.It is also uncertain if the severe oversizing (28mm bifurcate within a 20mm diameter neck) may have also contributed.A single angio image could not confirm any type ia endoleak; however, a possible type iv endoleak was seen along both sides of the stent graft.

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: 4100181
• MDR Text Key: 17163691
• Report Number: 2953200-2014-01864
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2015
• Device Catalogue Number: ETBF2813C145EJ
• Device Lot Number: V04016755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2014
• Initial Date FDA Received: 09/18/2014
• Date Device Manufactured: 04/02/2013
• 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 Age: 00079 YR