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

Catalog Number ETLW1616C82E

Device Problem Inaccurate Delivery (2339)

Patient Problems Death (1802); Vascular Dissection (3160)

Event Date 01/23/2014

Event Type  Death  

Event Description

An endurant ii stent graft system was implanted for the endovascular treatment of a 6.4 cm diameter abdominal aortic aneurysm.It was reported that the physician implanted the bifurcated main body and limb stent grafts.The stent grafts were deployed, but after the surgery, it was determined that a wire had most likely caused an aortic dissection.This resulted in the proximal part of the bifurcate and suprarenal fixation being deployed in a false lumen.The patient underwent an explant of the system and received a conversion.Three anchor pins from the suprarenal fixation remained in the patient, as the physician believed that time was of the essence.The surgeon felt that the patient's age and condition of the aorta made survival unlikely.The patient lost a large quantity of blood during the conversion surgery.It was reported that the patient subsequently died.The surgeon acknowledged that this was no fault of mdt product or support.There was no way to know that a dissection had occurred after initial angio and then before main body deployment.Review of returned films pre-implant ((b)(4) 2013) revealed a long neck which contained thrombus.The proximal neck diameter was 21 x 25mm just below the renals, and contained thrombus which had a dissection appearance near the renals.Approximately 5cm below the renals, there was a 5cm diameter x 4cm length aaa which also contained thrombus.The distal aorta id (flow lumen) was 15mm and calcified, and both iliacs were calcified.Images during and post-implant were not provided.The cause of the events could not be determined from these images.

Manufacturer Narrative

Exact date of death is unknown.(b)(4).Evaluation, results: inherent risk of procedure (arterial dissection, death); patient¿s condition affected effectiveness of device (thrombus, calcified iliacs); caused by another drug/device (guide wire).Conclusion: device failure/lack of effectiveness related to patient condition (thrombus, calcified iliacs); known inherent risk of a procedure (arterial dissection, death); another device caused failure (guide wire).

• 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: 3634308
• MDR Text Key: 4180903
• Report Number: 2953200-2014-00290
• 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: 01/23/2014

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: 10/14/2015
• Device Catalogue Number: ETLW1616C82E
• Device Lot Number: V04132544
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2014
• Date Device Manufactured: 10/15/2013
• 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): Death
• Patient Age: 00085 YR