MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	PLC231000
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Please note: this medwatch report is associated with mfr# 2953161-2019-00028.Additional device involved in this event: gore® excluder® iliac branch component (b)(4)/16240389 with udi (b)(4).
Event or Problem Description
The following information was reported to gore: on (b)(6) 2017, this patient underwent endovascular treatment for an abdominal aortic aneurysm and an aneurysm of the common iliac artery.The patient was therefore implanted with gore® excluder® aaa endoprostheses as well as gore® excluder® iliac branch endoprostheses.Reportedly, the procedure went well.On an unknown date, follow-up computed tomography imaging identified a type iii endoleak involving a disconnection between the gore® excluder® contralateral leg component plc231000 and the gore® excluder® iliac branch component (b)(4).There were no specific adverse anatomical issues and a cause for the disconnection was reportedly unknown.On (b)(6) 2019, the disconnection was relined with an additional gore® excluder® contralateral leg component and no endoleak was observed during final imaging.The patient tolerated the procedure.
Additional Manufacturer Narrative
Please note: this medwatch report is associated with mfr# 2953161-2019-00028.H6: code 22 - according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: endoleak.
Event or Problem Description
On february 17, 2019, follow-up computed tomography imaging identified a type iii endoleak involving a disconnection between the gore® excluder® contralateral leg component plc231000 and the gore® excluder® iliac branch component ceb231410.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8443032
• Report Number: 2953161-2019-00027
• Device Sequence Number: 13522487
• Product Code: MIH
• UDI-Device Identifier: 00733132618576
• UDI-Public: 00733132618576
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2019
• Device Catalogue Number: PLC231000
• Device Lot Number: 15768138
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 06/04/2019
• 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: Hospitalization; Required Intervention