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

Catalog Number ETCF2525C49E

Device Problem Inaccurate Delivery (2339)

Patient Problems Occlusion (1984); Renal Failure (2041)

Event Date 01/10/2014

Event Type  Injury  

Event Description

An aneurx stent graft system was implanted for the endovascular treatment of an abdominal aortic aneurysm.Aneurysm and vessel morph ology from the time of implant were not reported.It was reported that the patient presented with a proximal type i endoleak.The stent graft was found to have migrated 1.5 cm from the renal arteries.The stent graft migration was caused by sharp neck angulation of greater than 60 degrees.One day later, the patient was treated with a 25x25x49 endurant cuff, which successfully resolved the endoleak; however, it covered the right renal artery.The cause of the renal occlusion was due to the cuff being placed too high unintentionally.The physician attempted for three hours with an unknown manufacturer's balloon to pull the cuff down but was unsuccessful.The patient was placed on dialysis.No additional clinical sequelae were reported.

Manufacturer Narrative

(b)(4).Evaluation, results: inherent risk of procedure (vessel occlusion, renal complications), patient's condition affected effectiveness of device (aortic neck angulation), unapproved use of device (stent graft was implanted in a patient with an aortic neck angulation greater than 60 degrees); evaluation, conclusion: known inherent risk of a procedure (vessel occlusion, renal complications), device failure/lack of effectiveness related to patient condition (aortic neck angulation), off ¿ label, unapproved or contraindicated use (stent graft was implanted in a patient with an aortic neck angulation greater than 60 degrees).

• 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: 3603790
• MDR Text Key: 4068087
• Report Number: 2953200-2014-00161
• 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: 01/10/2014

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: 06/04/2015
• Device Catalogue Number: ETCF2525C49E
• Device Lot Number: V04058520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2014
• Initial Date FDA Received: 02/03/2014
• Date Device Manufactured: 06/18/2013
• 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: 00073 YR