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

Catalog Number	PXT281216
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Pain (1994)
Date of Event	07/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: patient medications: aspirin, b-complex, calcium carbonate, eye drops, losartan, mega red-krill, timoptic & xalatan.The gore® excluder® aaa endoprosthesis instructions for use (ifu) states that adverse events that may occur and/or require intervention include, but are not limited to aneurysm enlargement and rupture.Additional devices implanted and/or related to this event: pxc121200/06050659, udi: (b)(4).
Event or Problem Description
On (b)(6) 2008, the patient had three gore® excluder® aaa endoprostheses implanted to repair an abdominal aortic aneurysm (aaa).On (b)(6) 2019, the patient had a ct scan due to a complaint of abdominal pain and enlargement of her abdominal area.The physician discussed having an additional surgery to repair the aaa, but the patient declined.On (b)(6) 2019, the patient presented at the emergency department with a ruptured right common iliac artery.It was reported that due to the growth of the aaa, there was no longer a sufficient seal from her previously implanted grafts and the artery became pressurized and ruptured.The right common iliac artery was extended with two gore® excluder® aaa endoprostheses to repair the rupture.The physician also decided to implant two additional gore® excluder® aaa endoprostheses.An aortic cuff was placed just below the renal arteries and a contralateral limb was placed to extend the left limb.Reportedly there were no leaks in those locations, but he physician felt it best to gain additional coverage.The patient reportedly tolerated the procedure.
Additional Manufacturer Narrative
B3: corrected date of event to (b)(6), 2019.

• 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: 8846748
• Report Number: 3013164176-2019-00099
• Device Sequence Number: 290976
• Product Code: MIH
• UDI-Device Identifier: 00733132610273
• UDI-Public: 00733132610273
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2019

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: 05/31/2011
• Device Catalogue Number: PXT281216
• Device Lot Number: 06040469
• 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: 07/31/2019
• Supplement Report FDA Received Date: 08/13/2019
• 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
• Patient Age: 83 YR