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

Catalog Number	PXC141200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: as gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: pxc161200/06847605, udi:(b)(4), pxl161007/06697108, udi: (b)(4).According to the instructions for use (ifu) for the gore® excluder® aaa endoprosthesis; adverse events that may occur include, but are not limited to include: aneurysm enlargement.A review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.
Event or Problem Description
On (b)(6) 2009, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses.The patient tolerated the procedure with no reported issues.It was reported that the distal seal zone of both legs was short (distance unknown).On an unknown date, late follow- up post-operative imaging identified enlargement of the aneurysm.The amount of enlargement was unknown.No endoleak was observed at this time and the cause of aneurysm enlargement was unable to be determined.On (b)(6) 2019, the patient underwent reintervention and additional devices were implanted to extend the legs on both sides.Final angiography showed no issues.The patient tolerated the procedure.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8504831
• Report Number: 2953161-2019-00030
• Device Sequence Number: 1147803
• Product Code: MIH
• UDI-Device Identifier: 00733132609956
• UDI-Public: 00733132609956
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2019

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: No Information
• Device Expiration Date: 03/31/2012
• Device Catalogue Number: PXC141200
• Device Lot Number: 06664445
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2019
• 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; Other; Required Intervention
• Patient Age: 82 YR