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

Catalog Number ETBF3216C166E

Device Problems Leak/Splash (1354); Separation Failure (2547)

Patient Problem Injury (2348)

Event Date 03/13/2015

Event Type  Injury  

Event Description

An endurant ii stent graft system was implanted for the endovascular treatment of a 6.7 cm in diameter ruptured abdominal aortic aneurysm.The vessel morphology was reported as the proximal aortic neck as 25 mm in diameter, and 29 mm in diameter 40 mm below renal artery.It was reported that a ct revealed a proximal type i endoleak and that the proximal bare stent (suprarenal fixation) got pulled down.At the index procedure it did not appear that the suprarenal struts were inverted.However the recent ct revealed that the proximal component of the bifurcated stent graft folded in on themselves.It was reported that this most likely happened when removing catheters and wires at the end of the index procedure.The physician elected to implant an endurant cuff 32x32x49 and the proximal type i endoleak was resolved.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

(b)(4).

• Brand Name: ENDURANT
• 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: eric elliott ; 3576 unocal place; santa rosa, CA 95403 ; 7075912586
• MDR Report Key: 4704506
• MDR Text Key: 5722956
• Report Number: 2953200-2015-00745
• 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: 03/23/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2016
• Device Catalogue Number: ETBF3216C166E
• Device Lot Number: V05979334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2015
• Initial Date FDA Received: 04/17/2015
• Date Device Manufactured: 11/26/2014
• 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