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

Catalog Number ETBF2816C145E

Device Problem Inaccurate Delivery (2339)

Patient Problem Occlusion (1984)

Event Date 01/22/2014

Event Type  Injury  

Event Description

An endurant stent graft system was implanted in the patient for the endovascular treatment of an abdominal aortic aneurysm.Aneurysm and vessel morphology at the time of implant was reported as the proximal neck diameter is 23mm and the proximal neck length is 2cm.The degree of angulation is 30.Vessel tortuosity at implant was noted as mild to moderate.Vessel calcification was noted as mild.During the index procedure the physician accidentally placed the bifurcation too high due to the renal artery take off incorrectly identified by the physician.The physician covered approximately 80 percent.No additional clinical sequelae were reported and the patient will be monitored by the physician.

Manufacturer Narrative

(b)(4).Results: vessel occlusion, inaccurate stent graft delivery.User error.Conclusion: vessel occlusion, inaccurate stent graft delivery.User error.

• 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: 3623028
• MDR Text Key: 4132149
• Report Number: 2953200-2014-00213
• 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: 01/22/2014

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: 09/24/2015
• Device Catalogue Number: ETBF2816C145E
• Device Lot Number: V04122369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2014
• Initial Date FDA Received: 02/11/2014
• Date Device Manufactured: 09/25/2013
• 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: 00079 YR