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

Catalog Number ETBF2316C166EJ

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2014

Event Type  Injury  

Event Description

An endurant ii stent graft system were implanted for the endovascular treatment of an abdominal aortic aneurysm.The proximal aortic neck was between 16 and 19 mm, with a length of 33 mm and an angulation of 56 degrees.The arteries were reported to have numerous calcifications.It was reported that during the index procedure, due to the tortuous anatomy of the aortic neck, the physician attempted to advance the stent graft to follow the curvature of the artery.As a result, the stent graft was advanced proximally beyond the planned location, which resulted in occlusion of the lower renal artery.Patient was reported to be stable and no further intervention is planned.The physician commented: push-up was attempted to implant the stent graft for the purpose of following the greater curvature of tortuous neck.As a result, the stent graft was entirely migrated to upper side, which unexpectedly covered the lower renal artery.

Manufacturer Narrative

(b)(4).Evaluation, results: inherent risk of procedure (vessel occlusion); unapproved use of device (proximal neck is less than 19 mm in diameter, neck angulation greater than 60 degrees); conclusion: known inherent risk of a procedure (vessel occlusion); off-label, unapproved or contraindicated use (proximal neck is less than 19 mm in diameter, neck angulation greater than 60 degrees).(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: 3600919
• MDR Text Key: 4193679
• Report Number: 2953200-2014-00145
• 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,Followup
• Report Date: 02/14/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2015
• Device Catalogue Number: ETBF2316C166EJ
• Device Lot Number: V04085325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2014
• Initial Date FDA Received: 01/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/19/2014
• Date Device Manufactured: 07/17/2013
• 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: 00080 YR