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

Model Number	PXT261218
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device remains implanted and is not available for analysis.(b)(4).Further information was requested but was not available.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include but are not limited to endoleak and aneurysm enlargement.Additionally, per ifu, intervention or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing enlarging aneurysms and / or persistent endoleak.Users are made aware of the risks associated with type ii endoleaks in the ifu and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.Please note as the date when the endoleaks and aneurysm enlargement were determined is unknown, (b)(6) 2016- embolization procedure date will be used as an event date.Please note that the physician/facility contact information is: (b)(6).
Event or Problem Description
On (b)(6) 2014, the patient was implanted with a gore® excluder® aaa endoprosthesis for an abdominal aortic aneurysm.Reportedly, after procedure images confirmed that there was no complications or issues.The patient tolerated the procedure.On an unknown date, during a control ct scan, it was observed that the aneurysmatic sac had increased (unknown amount).Also, a type ii endoleak was determined.On (b)(6) 2016, the endoleak was embolized.On an unknown date, almost 3 years after embolization procedure, the patient presented with an abdominal pain.During another image exam, it was noted that the aneurysm had increased in size (unknown amount) and the patient was submitted to another procedure.Reportedly, on (b)(6) 2019, an aortic cuff was implanted.On an unknown date in 2020, the patient was hospitalized due to a strong abdominal pain.It was reported that the aneurysm increased too much, and the patient underwent endovascular procedure using a medtronic device (proximal reinforcement through anchors).As there was no sign of the aneurysm being reduced, the physician did not believe that there was a possibility of type i , type ii or type iii endoleaks.The physician suspected that there is a possibility of a type iv endoleak.Further information was requested but was not available.

• 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
• MDR Report Key: 11780295
• Report Number: 2953161-2021-01061
• Device Sequence Number: 3831129
• Product Code: MIH
• UDI-Device Identifier: 00733132610204
• UDI-Public: 00733132610204
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2021

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: 03/31/2015
• Device Model Number: PXT261218
• Device Catalogue Number: PXT261218
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 05/05/2021
• 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: 86