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

Model Number	PLC161000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medications include but are not limited to: pacemaker; cardiac catheterization; right knee arthroscopy; medications: gabapentin 100mg; latanaprost.005%; irbesartan 75mg; vitron c 65-125mg; lasix 40mg; xarelto 20mg; amlodipine besylate 5 mg; methimazole 5 mg; zantac 150mg; aspirin 81mg; coreg 12.5mg; rosuvastatin 20mg.
Event or Problem Description
On (b)(6) 2017, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with four gore® excluder® aaa endoprostheses.The patient tolerated the procedure.On (b)(6) 2020, the patient presented with an enlarging aneurysmal left common iliac artery (lcia) just distal to the contralateral leg component originally placed.The patient underwent reintervention and an additional contralateral leg component was placed to extend coverage and obtain good seal just prior to the origin of the left hypogastric artery.Good distal seal was achieved.The patient tolerated the procedure with good results.The physician attributed the enlargement of the lcia to disease progression.
Additional Manufacturer Narrative
H6: code 213: a review of the manufacturing records verified the lot met pre-release specifications.

• 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: 10144571
• Report Number: 3013164176-2020-00081
• Device Sequence Number: 14093539
• Product Code: MIH
• UDI-Device Identifier: 00733132618668
• UDI-Public: 00733132618668
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2020

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: 09/13/2018
• Device Model Number: PLC161000
• Device Catalogue Number: PLC161000
• Device Lot Number: 14269307
• 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: 06/11/2020
• Supplement Report FDA Received Date: 06/19/2020
• 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: 84 YR
• Patient Weight: 88