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

Catalog Number ETUF3214C102E

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2014

Event Type  malfunction  

Event Description

An endurant ii stent graft system was implanted for the endovascular treatment of a 65mm diameter and 120mm in length abdominal aortic aneurysm.The proximal neck was 25 mm in diameter and 20 mm in length.The proximal neck had moderate calcification.The right iliac was severely calcified, and the left iliac was moderately calcified.It was reported that while bringing the nose cone back through the graft, the nose cone caught on the suprarenal stent.The anchoring pins of the suprarenal stent then became entangled.The nose cone was successfully withdrawn.An unsuccessful attempt was made to correct the entanglement with a reliant balloon.There is no endoleak and the stent seems to be against the aortic wall.The physician does not think that the stents are sticking into the aorta because we were able to pass an inflated reliant past the stent without any deformation of the balloon or stent.No clinical sequelae were reported and the patient is fine.A review of a single returned still angiogram image at implant confirmed that 2 or 3 of the suprarenal stents appeared entangled at their pins.The proximal markers were also not in the same plane.The cause of the entanglement could not be determined.

Manufacturer Narrative

(b)(4).Evaluation, conclusion: (unknown cause of event).(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: ludmila voulfson ; 3576 unocal place; santa rosa, CA 95403 ; 7075661229
• MDR Report Key: 3863863
• MDR Text Key: 4570138
• Report Number: 2953200-2014-01162
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2015
• Device Catalogue Number: ETUF3214C102E
• Device Lot Number: V04112541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2014
• Date Device Manufactured: 09/06/2013
• 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: 00084 YR