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 Problems Occlusion (1984); Pain (1994)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: month and year only valid.If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 49.5mm diameter abdominal aortic aneurysm.During the index procedure, due to calcification present another manufacturer's stent was also placed with the kissing technique to ensure limb patency.The patient's iliac arteries ranged from 7.7-14.5mm.It was reported that the patient complained of suffering with pain in her leg since approximately 4 months post index procedure.A ct showed a thrombotic occlusion in the area from the contralateral side of the flow divider to the eia.Although partial stenosis was observed on the contralateral side of the terminal aorta the limb was not completely collapsed.As per the physician, the cause of the event was anatomy related due to narrowing and significant calcification in the terminal aorta.It was also noted that the patient had a low ankle-brachial index, low compliance with medication and had left the leg pain untreated.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: 7391408
• MDR Text Key: 104273847
• Report Number: 2953200-2018-00468
• 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: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2019
• 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: 03/08/2018
• Initial Date FDA Received: 04/03/2018
• Date Device Manufactured: 02/22/2017
• 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 Age: 82 YR