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

Model Number	PXT261414
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Vascular Dissection (3160); Clinical Endoleak (4843)
Date of Event	11/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Also was implanted: pxc161400/ 10667830, udi# (b)(4).Additional information was requested but is not available.Based on the conversation with the physician, the event was not related with the device or procedure.Several attempts to contact the site again were made, unsuccessfully, to get more information.Based on current information available, the event is due to the disease progression.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to dissection, aneurysm enlargement and endoleak.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.
Event or Problem Description
On (b)(6) 2014, this patient underwent endovascular treatment for a type b uncomplicated aortic dissection and was implanted with gore® excluder® aaa endoprostheses (pxt261414/11132081 and pxc161400/10667830).An aortic branch vessel procedure was also performed on the left renal artery, wherein it was stented with a stent express ¿ sd (boston scientific) endoprosthesis.The patient tolerated the procedure and was discharged on february 12, 2014 with no reported endoleak or other complications.On (b)(6) 2015, follow up computed tomography angiography (cta) determined the maximum diameter of the aortic aneurysm/lesion measured 36mm.Follow up computed tomography angiography (cta) on (b)(6) 2018, determined the maximum diameter of the aortic aneurysm/lesion was measured 59mm.Additionally, on (b)(6) 2018, an endoleak and a dissection were noted.On (b)(6) 2019, the patient underwent the embolization procedure using dmso.Also, the additional aortic endograft was implanted and the endarterectomy procedure for both femoral artery was performed.According to the site, the event was not related to device or procedure.Additional information was requested from the site.Based on the conversation with the physician, the event was not related with the device or procedure.Several attempts to contact the site again were made, unsuccessfully, to get more information.Based on current information available, the event is due to the disease progression.
Additional Manufacturer Narrative
B3: corrected date of event from 11/18/2018 to 11/13/2018.

• 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 PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15397807
• Report Number: 3007284313-2022-02108
• Device Sequence Number: 4947201
• Product Code: MIH
• UDI-Device Identifier: 00733132610228
• UDI-Public: 00733132610228
• 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: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2022

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: 01/31/2016
• Device Model Number: PXT261414
• Device Catalogue Number: PXT261414
• 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: 08/24/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 09/10/2022
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2013
• 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: Other; Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 52 KG