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

Catalog Number ETTF3636C70E

Device Problems Use of Device Problem (1670); Inaccurate Delivery (2339)

Event Date 02/12/2013

Event Type  Injury  

Event Description

It was reported that the physician performed a secondary intervention to resolve a proximal type i endoleak.The physician implanted an endurant cuff and snorkeled the left renal and superior mesenteric artery.The physician was unable to cannulate the right renal artery so it was decided to be covered.The patient is doing well and the endoleak has resolved.

Manufacturer Narrative

(b)(4).Evaluation, method: (unknown cause of event); evaluation, conclusion: (unknown cause of event).

• 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: 3550365
• MDR Text Key: 16054624
• Report Number: 2953200-2014-00007
• 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: 12/10/2013

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: 07/26/2015
• Device Catalogue Number: ETTF3636C70E
• Device Lot Number: V04091424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2013
• Initial Date FDA Received: 01/03/2014
• Date Device Manufactured: 07/26/2013
• 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