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

Catalog Number ETBF3620C145E

Device Problems Leak/Splash (1354); Inaccurate Delivery (2339)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/27/2014

Event Type  Injury  

Event Description

An endurant ii stent graft system was implanted for the endovascular treatment of a 5.2 cm in diameter abdominal aortic aneurysm.The patient had a short reverse funnel neck measuring 28-31 mm in diameter and 10 mm in length.It was reported that during the index procedure, while ballooning the endurant bifurcate, the stent graft slipped down 3-4 mm.The final angiogram revealed a proximal type i endoleak, the physician implanted an endurant cuff resolving the endoleak.No clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

(b)(4).Evaluation, results: inherent risk of procedure (inaccurate delivery, endoleak), patient's condition affected effectiveness of device (anatomy related; ballooning the stent graft within the short and conical proximal neck); evaluation, conclusion: known inherent risk of a procedure (inaccurate delivery, endoleak), device failure/lack of effectiveness related to patient condition (anatomy related; ballooning the stent graft within the short and conical proximal neck).

• 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: 3634186
• MDR Text Key: 21658816
• Report Number: 2953200-2014-00289
• 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: 01/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2014
• Device Catalogue Number: ETBF3620C145E
• Device Lot Number: V01083379
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2014
• Date Device Manufactured: 05/09/2012
• 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: 00069 YR