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

Catalog Number	PXT261414
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pain (1994)
Date of Event	04/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: medications: aspirin, q-10 enzyme, lopressor, avapro, crestor, sinamet & aricept.The review of the manufacturing paperwork verified that the lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and/or require intervention include, but are not limited to, endoleak.
Event or Problem Description
On (b)(6) 2006 the patient had three gore® excluder® aaa endoprostheses implanted.On (b)(6) 2019, the patient was admitted to the emergency room with symptoms of back pain and hypotension.A ct scan was performed but did not show any results.The patients symptoms continued and on (b)(6) 2019 an angiogram was performed and what looked like a hole appeared in the previously implanted gore® excluder® aaa endoprosthesis main body right below the flow divider.On (b)(6) 2019, a gore® excluder® aaa endoprosthesis was implanted inside the original gore® excluder® aaa endoprosthesis mainbody and it was reported that the hole was successfully covered and the patient tolerated the procedure.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (ORIGINAL)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8597800
• Report Number: 2017233-2019-00334
• Device Sequence Number: 2346231
• Product Code: MIH
• UDI-Device Identifier: 00733132610228
• UDI-Public: 00733132610228
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/19/2019

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: 09/30/2008
• Device Catalogue Number: PXT261414
• Device Lot Number: 04008115
• 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: 05/09/2019
• 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: 73 YR
• Patient Weight: 95