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

Model Number	ENLW1613C124E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Aneurysm (1708)
Date of Event	03/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 55mm abdominal aortic aneurysm.It was reported that the patient presented emergently with abdominal pain approximately seven years later and ct showed a type ib endoleak on the right.It was noted that the right common iliac artery had dilated and now measured 30mm.The original implant on this side had a 20mm diameter.The physician coiled the right hypogastric and then implanted three limbs on the right side.It was noted that the left side iliac diameter had enlarged and was now 20mm with a 13mm diameter stent graft previously implanted, so another extension was also implanted here.The final angiogram showed resolution of the type ib endoleak and good perfusion to the left hypogastric artery.As per the physician, the cause of the event was anatomy related due to natural history of aneurysm disease.No additional clinical sequelae were reported and the patient is fine.

• Brand Name: ENDURANT ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8517502
• Report Number: 2953200-2019-00509
• Device Sequence Number: 13819509
• Product Code: MIH
• UDI-Device Identifier: 00613994761972
• UDI-Public: 00613994761972
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/16/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/06/2013
• Device Model Number: ENLW1613C124E
• Device Catalogue Number: ENLW1613C124E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR