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

Model Number	PXT261416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/01/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2008, this patient underwent endovascular treatment for an abdominal aortic aneurysm which had been previously (date unknown) treated with endologix devices.Gore® excluder® aaa endoprostheses were implanted to reline the endologix devices.The patient tolerated the procedure.On (b)(6) 2023, the patient underwent reintervention for an enlarging aneurysm and a type iii endoleak associated with a hole in a dacron graft and gore® excluder® aaa contralateral limb was implanted to reline the dacron graft.The gore associate supporting this procedure was made aware at this time, that the gore devices had been explanted and a dacron graft had been sewed in on an unknown date and year but thought to have been ten or so years ago.No additional information regarding the explant was known.The patient tolerated the procedure.The date of event (explant) is estimated to be on or about (b)(6) 2013, the reintervention on (b)(6) 2023 is not relevant as there were no gore devices associated with the type iii endoleak.
Additional Manufacturer Narrative
Patient medical history includes but is not limited to: hyperlipidemia, hypertension, seep apnea, aortic stenosis, covid-19 concomitant medical product(s): patient medications include but are not limited to: vancomycin, cardizem, metroprolol tartrate, monodox, lipitor, zetia, eliquis, adverse event problem: code d1101: according to the instructions for use(ifu), the safety and effectiveness of the gore® excluder® aaa endoprosthesis has not been evaluated in the following patient populations: revision of previously placed stent grafts.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16736959
• Report Number: 2953161-2023-01173
• Device Sequence Number: 17791419
• Product Code: MIH
• UDI-Device Identifier: 00733132610235
• UDI-Public: 00733132610235
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/13/2023

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: 09/30/2010
• Device Model Number: PXT261416
• Device Catalogue Number: PXT261416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/13/2023
• Date Device Manufactured: 10/16/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Sex: Male
• Patient Weight: 69 KG