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

Model Number ETLW1610C124EJ

Device Problems Occlusion Within Device (1423); Folded (2630)

Patient Problem Occlusion (1984)

Event Date 02/15/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant iis stent graft system was implanted in a patient for the endovascular treatment of a 44mm diameter saccular abdominal aortic aneurysm.The aorta had a diameter of 14-16.5 mm.The length of the proximal aortic neck was 58 mm.There was significant calcification present from the aortic neck to the distal area.It was reported that during the index procedure, an esbf2314c103ej was implanted proximally, and 2 etlw1610c124ej were implanted in the left and right distal regions.Kissing balloon technique was then performed with two non-medtronic (coda and gekira) balloons.Due to the narrow terminal aorta (diameter 14 mm), and narrow left and right common iliac arteries (diameter 8-8.2 mm), non-medtronic (epic) bare metal stents were also implanted on bothsides.The stents were placed from the distal section of the main body, where the stent graft was not overlapped, to the distal edge.After implantation, kissing balloon technique was again used on both sides and the procedure was completed.It is reported that on the same day as the procedure, occlusion occurred just below the flow divider on the contralateral side.It is noted that pta ballooning and thrombectomy was performed in the contralateral leg etlw1610c124ej on the proximal site to treat the occlusion and that a main body occlusion issue was not reported.The event was resolved.The physician stated the cause of the event was related to the kissing balloon technique.The tapered tip of one of the balloons (gekira) was possibly placed just below the flow divider on the contralateral side (the proximal edge of the limb).Because of this, the physician suspected that the proximal edge of the limb could not be fully expanded.No additional clinical sequelae were reported and the patient will be monitored by their physician.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 7327307
• MDR Text Key: 101994933
• Report Number: 2953200-2018-00357
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2019
• Device Model Number: ETLW1610C124EJ
• Device Catalogue Number: ETLW1610C124EJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2018
• Initial Date FDA Received: 03/09/2018
• Date Device Manufactured: 04/06/2017
• 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: 71 YR