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

Model Number	RLT281418
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	12/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
The following information was reported to gore through the ide study for the iliac branch endoprosthesis (ibe): on (b)(6) 2016, the patient underwent treatment of a 51 mm abdominal aortic aneurysm and 33 mm left iliac artery aneurysm with gore® excluder® aaa endoprostheses and gore® iliac branch endoprostheses.Completion angiography showed no evidence of endoleak, and the patient tolerated the procedure.On (b)(6) 2017 the maximum aortic diameter was 51mm.On (b)(6) 2020 a type ia endoleak was detected.The maximum aortic diameter was 61mm.The event is ongoing.
Additional Manufacturer Narrative
H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.
Event or Problem Description
The following information was reported to gore through the ide study for the iliac branch endoprosthesis (ibe): on (b)(6) 2016, the patient underwent treatment of a 51 mm abdominal aortic aneurysm and 33 mm left iliac artery aneurysm with gore® excluder® aaa endoprostheses and gore® iliac branch endoprostheses.Completion angiography showed no evidence of endoleak, and the patient tolerated the procedure.On (b)(6) 2020 a type ia endoleak was detected.On (b)(6) 2021 a reintervention occurred in which the patient was implanted with a non-gore aortic cuff (endurant) which was placed at the level of the left renal artery just above the bifurcation of the gore® excluder® aaa endoprosthesis.After ballooning there was no observed endoleak and it appeared to have been resolved.Ct imaging on (b)(6) 2021 showed no type 1a endoleak, confirming the resolution.It also showed the presence of a type ii ma endoleak.The decision was made to follow up in one year.The event is still ongoing.
Additional Manufacturer Narrative
B2: required intervention to prevent permanent impairment/damage.B3 / b4 / b5 / b6: on december 28th 2021 the additional information regarding the event was provided: on (b)(6) 2021 a reintervention occurred in which the patient was implanted with a non-gore aortic cuff (endurant) which was placed at the level of the left renal artery just above the bifurcation of the gore® excluder® aaa endoprosthesis.After ballooning there was no observed endoleak and it appeared to have been resolved.Ct imaging on (b)(6) 2021 showed no type 1a endoleak, confirming the resolution.It also showed the presence of a type ii ma endoleak.The decision was made to follow up in one year.The event is still ongoing.

• 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: heidi inskeep ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10950249
• Report Number: 3007284313-2020-01185
• Device Sequence Number: 11635404
• Product Code: MIH
• UDI-Device Identifier: 00733132622559
• UDI-Public: 00733132622559
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/28/2021

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: 04/27/2018
• Device Model Number: RLT281418
• Device Catalogue Number: RLT281418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 12/07/2020; 12/07/2020
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 02/16/2021; 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2015
• 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; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 120 KG