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

Model Number	PXT281218
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.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 endoleak.
Event or Problem Description
The following was reported to gore.On (b)(6) 2011, a patient underwent a treatment of abdominal aortic aneurysm with gore® excluder® aaa endoprostheses.During the procedure, gore® excluder® aaa trunk-ipsilateral leg endoprosthesis and contralateral leg endoprosthesis were implanted.The patient tolerated the procedure.On a routine follow-up, images (date is unknown) revealed proximal aortic neck enlargement and aneurysm enlargement (amount unknown).On (b)(6) 2019, two additional gore® excluder® aortic extender endoprostheses were implanted.The patient tolerated the procedure.(it was reported although the left renal artery was partially covered by the device, there was no obstruction of blood flow.) the physician stated that no endoleak was confirmed on the image of the contrast enhanced computed tomography (ct), however, the aneurysm enlargement was probably caused by an endoleak.

• 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: 9504555
• Report Number: 2953161-2019-00069
• Device Sequence Number: 1541759
• Product Code: MIH
• UDI-Device Identifier: 00733132610280
• UDI-Public: 00733132610280
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

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: 03/31/2013
• Device Model Number: PXT281218
• Device Catalogue Number: PXT281218
• Device Lot Number: 7837475
• 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: 12/20/2019
• Supplement Report FDA Received Date: 03/26/2020
• 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; Required Intervention
• Patient Age: 67 YR