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

Catalog Number ETLW1616C124EJ

Device Problem Inaccurate Delivery (2339)

Patient Problem Occlusion (1984)

Event Date 12/17/2013

Event Type  Injury  

Event Description

An endurant stent graft system was implanted in the patient for the endovascular treatment of a 41mm in diameter abdominal aortic aneurysm.Vessel morphology at the time of implant was reported as the diameter of the upper proximal neck is 20mm and the diameter of aneurysm entry is 18mm.The proximal neck length by centerline is 30mm.The diameter of right common iliac is 14mm and 40mm in length.The diameter of the left common iliac is 15mm and 40mm in length.It was reported that during the index procedure an occlusion was confirmed for both sides of the internal iliac arteries.The physician stated that the x-ray tube was not rotated accurately which contributed to misjudgement of the internal iliac artery.In addition, the physician noted that after selecting the long iliac the physician pushed the stent graft in order to shorten the length.Both hypos remained covered by the stent grafts at the end of the procedure.No additional clinical sequelae were reported and the patient will be monitored by the physician.

Manufacturer Narrative

(b)(4).Evaluation, results: inherent risk of procedure (vessel occlusion, inaccurate stent graft delivery), related to operational context: (inaccurate delivery due to poor visualization); evaluation, conclusion: device failure/lack of effectiveness related to patient condition (vessel occlusion, inaccurate stent graft delivery), operational context contributed to event (inaccurate delivery due to poor visualization).

• 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: 3568631
• MDR Text Key: 4055868
• Report Number: 2953200-2014-00053
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2013

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: 05/24/2015
• Device Catalogue Number: ETLW1616C124EJ
• Device Lot Number: V04052906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2013
• Initial Date FDA Received: 01/10/2014
• Date Device Manufactured: 05/24/2013
• 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: 00073 YR