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

Catalog Number	PXC201000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products; patient medications include but are not limited to: proventil (90 mcg); aspirin (81mg); lotensin (20mg); buspar (30mg) keflex (500mg).Concomitant medical products: as gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: pxc201400/03467752, udi: (b)(4).According to the instructions for use (ifu) for the gore® excluder® aaa endoprostheses; adverse events that may occur include, but are not limited to include: embolization (micro and macro) with transient or permanent ischemia a review of the manufacturing records for the device(s) is being conducted.
Event or Problem Description
On (b)(6) 2005, this patient underwent endovascular treatment for an infrarenal abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses.On (b)(6) 2019, follow-up computed tomography angiography (cta) indicated approximately 3cm growth of the left common iliac artery (lcia) distal to the implanted device in the lcia on the contralateral side.Seal was still evident in the proximal lcia.On (b)(6) 2019, the patient underwent reintervention and the left internal iliac artery was coiled and two additional gore® contralateral leg components were implanted to bridge and extend coverage from the level of the flow divider down to the left external iliac artery.The patient tolerated the procedure with no reported issues and is doing well.
Additional Manufacturer Narrative
Code 213- a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.

• 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: 8613364
• Report Number: 2017233-2019-00350
• Device Sequence Number: 2522435
• Product Code: MIH
• UDI-Device Identifier: 00733132610037
• UDI-Public: 00733132610037
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2019

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: 12/31/2007
• Device Catalogue Number: PXC201000
• Device Lot Number: 03493266
• 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: 05/15/2019
• Supplement Report FDA Received Date: 05/16/2019
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 80