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

Catalog Number ETBF3616C166EJ

Device Problem Inaccurate Delivery (2339)

Event Date 12/26/2013

Event Type  Injury  

Event Description

An endurant stent graft system was implanted in the patient for the endovascular treatment of a 58mm fusiform abdominal aortic aneurysm.Vessel morphology at the time of implant was reported as the diameter of the upper proximal neck is 28mm and 29mm in diameter of aneurysm entry.The proximal neck length by centreline is 66mm and 20 degree angulation.It was reported that during the index procedure the final dsa confirmed that the distal side of the fabric slightly covered the left renal artery which led to decreased on blood flow.The physician added another manufacturer¿s stent and blood flow was restored.The procedure was completed successfully.The physician noted that during delivery for the proximal side, cranial view (cra) was not checked with an accurate angle, which caused slight difference of parallax.Therefore, the device slightly covered the left renal artery.The physician attributed the event to the operation, not the device.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).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: 3581475
• MDR Text Key: 19728436
• Report Number: 2953200-2014-00074
• 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: 12/26/2013

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: 06/09/2015
• Device Catalogue Number: ETBF3616C166EJ
• Device Lot Number: V04061823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2013
• Initial Date FDA Received: 01/17/2014
• Date Device Manufactured: 06/13/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 00086 YR