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

Catalog Number ETBF3216C145E

Device Problem Inaccurate Delivery (2339)

Event Date 01/23/2014

Event Type  Injury  

Event Description

An endurant ii stent graft system was implanted for the endovascular treatment of an abdominal aortic aneurysm.The patient had a single right renal artery and two left renal arteries.It was reported that when deploying the stent graft the angio confirmed the stent graft was below the two left renal arteries which were the lowest.Upon completion of the final angiogram all renal arteries appeared patent.However after reviewing the angiogram it appeared one of the proximal stent graft markers was partially in the left renal artery.The physician decided to place two renal stents one in each of the two left renal arteries without incident.The cause of the occlusion was determined to be due to poor visualization as both left renal arteries were superimposed over each other.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

(b)(4).Evaluation, results: inherent risk of procedure (vessel occlusion), caused by another drug/device (poor visualization); evaluation, conclusion: known inherent risk of a procedure (vessel occlusion), another device caused failure (poor visualization).

• 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: 3633006
• MDR Text Key: 17949799
• Report Number: 2953200-2014-00284
• 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: 01/23/2014

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: 10/16/2015
• Device Catalogue Number: ETBF3216C145E
• Device Lot Number: V04136406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2014
• Initial Date FDA Received: 02/18/2014
• Date Device Manufactured: 10/18/2013
• 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: 00066 YR