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

Catalog Number ETBF2516C166EJ

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2013

Event Type  Injury  

Event Description

An endurant stent graft system was implanted in a patient for the endovascular treatment of a 52 mm x 154 mm abdominal aortic aneurysm.The proximal neck diameter was 17mm, the distal neck diameter was 21mm, and the length was 15mm.Percutaneous approach was performed with ultra sound of the left contralateral limb.It was reported that delivery, deployment, removal of the left contralateral limb was difficult and the delivery system was pushed several times.The cause of delivery difficulty was that the guide wire was accidentally inserted into one of the suprarenal stents which encroached on the outside of suprarenal stent, which caused the tip of the contralateral limb to get stuck on the suprarenal stent of the bifurcated stent during cannulation.The final angiography showed that left renal artery had slow blood flow and ballooning was attempted.This was not successful and the left renal artery was occluded.Ivus was performed for evaluation.Angiography showed the left renal artery was covered by the proximal portion of the stent graft.No further intervention was performed and the decision was made to monitor the patient.No additional clinical sequelae were reported.The physician commented that the tip of the contralateral limb pushed the suprarenal stent, which might have caused the stent graft to move upwards and cover the renal artery.Or the patient originally had many a lot of thrombi, which might have occluded the renal artery.

Manufacturer Narrative

(b)(4).Evaluation, results: inherent risk of procedure (occlusion), patient¿s condition affected effectiveness of device (emboli), caused by another drug/device (contralateral limb delivery system); additional: failure to follow instructions (guide wire inserted into the suprarenal stent), unapproved use of device (proximal neck is less than 19 mm in diameter); evaluation, conclusion: known inherent risk of a procedure (removal difficulty), device failure related to patient condition (emboli), another device caused failure (guide wire), use error caused or contributed to the event (guide wire inserted into the suprarenal stent); additional: off ¿ label, unapproved or contraindicated use (proximal neck is less than 19 mm in diameter).

• Brand Name: ENDURANT II
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDRONIC 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: 3567839
• MDR Text Key: 4217311
• Report Number: 2953200-2014-00045
• 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: 12/17/2013

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: 07/25/2015
• Device Catalogue Number: ETBF2516C166EJ
• Device Lot Number: V04091810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2013
• Initial Date FDA Received: 01/10/2014
• Date Device Manufactured: 07/25/2013
• 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: 00085 YR