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 Codes	Aneurysm (1708); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.The device remains implanted, therefore a direct product analysis could not be conducted.(b)(4).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 it states: 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.Due to the information provided that it was a persistent type ii endoleak (not a new one), the date of event will be used (b)(6) 2018 ¿ the date the type ii endoleak was reported.
Event or Problem Description
On (b)(6) 2014 a patient underwent treatment of an abdominal aortic aneurysm measuring 80mm with gore® excluder® aaa endoprostheses.On (b)(6) 2018 a cta revealed the aneurysm measured 85mm.On (b)(6) 2018 a type ii endoleak originating from lumbar branches originating from the right internal iliac artery was reported.The aneurysm measured 102mm by cta.On (b)(6) 2019 a reintervention took place.Initially micro-navigation was attempted to access the aneurysmal sac, but this was not successful.Therefore, the right internal iliac artery was embolized.(this information was captured in the event# 40243, medwatch# 2953161-2019-00033 was emailed to fda on (b)(6) 2019).The follow-up on (b)(6) 2019, showed that the maximum diameter of the aortic aneurysm/lesion was 116mm.Also, a type ii endoleak was determined.It was reported from the site that it was a persistent type ii endoleak which was treated on (b)(6) 2019.It was reported that the type ii endoleak attributed to the aneurysm enlargement.The perfusion of the wall from various branches such as, lumbar, intercostal and pelvic, increased the aneurysm sac.The endoleak origin was the lumbar artery hypertrophied which consequently increased the intercostal artery.It was reported that on (b)(6) 2021, the patient underwent an embolization procedure with microparticles (embosoft) 500/700.Reportedly, the type ii endoleak was resolved.The patient was clinically stable and programmed to have follow up appointments in a month, six month and annually.On (b)(6) 2021, the patient had a month follow up appointment without complaints or adverse signs and symptoms.
Additional Manufacturer Narrative
H6: component coded 515 added.H6: investigation conclusion code updated to include 22 only.

• 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11418376
• Report Number: 2953161-2021-01050
• Device Sequence Number: 20011451
• Product Code: MIH
• UDI-Device Identifier: 00733132610235
• UDI-Public: 00733132610235
• 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,Followup
• Report Date (Section B): 01/24/2022

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: 02/29/2016
• 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): Initial
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2013
• 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: Hospitalization; Required Intervention; Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Race: White