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

Model Number	RLT311415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	09/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The field sales associate reported the following: on (b)(6) 2015, the patient was implanted with a gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm (infrarenal-zone 9).The patient tolerated the procedure.It was reported that images (modality and date is unknown), revealed a proximal type i endoleak.There was aneurysm sac enlargement (amount of enlargement is unknown).Reportedly the patient had very tortuous anatomy, a severely angulated aortic neck and bilateral renal artery stenosis.There was a reintervention on (b)(6) 2022.The physician implanted three gore® excluder® aaa aortic extender endoprostheses in the proximal seal zone from the original procedure.The physician planned to cover the left renal artery, due to stenosis at the proximal connection to aorta and due to the severely angulated aortic neck.The first implanted aortic extender endoprosthesis (cxa360005/24322716) partially covered the left renal artery and was not long enough to cover the angulation.Two additional aortic extender endoprostheses were implanted for coverage of the angulation.The physician attempted to stent the partially covered left renal artery, but the terumo sheath buckled when advancing into the left renal artery.The left renal artery remained partially covered but was patent.The endoleak was resolved.The patient tolerated the reintervention procedure.
Additional Manufacturer Narrative
According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure related adverse events section includes but is not limited to 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.
Additional Manufacturer Narrative
H6: code c19 ¿ a review of the manufacturing records for the device verified that the lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure related adverse events section includes but is not limited to endoleak.B3: changed the event date from 9/27/2022 to 9/28/2022.

• 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 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15580019
• Report Number: 3007284313-2022-02154
• Device Sequence Number: 17728547
• Product Code: MIH
• UDI-Device Identifier: 00733132619085
• UDI-Public: 00733132619085
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: 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: 04/09/2018
• Device Model Number: RLT311415
• Device Catalogue Number: RLT311415
• 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: 09/27/2022
• Supplement Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 83 KG