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

Model Number	RLT281218
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states, adverse events that may occur and / or require intervention include but are not limited to: endoleak.
Event or Problem Description
On (b)(6) 2014, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprosthesis featuring c3® delivery system.The patient tolerated the procedure.On (b)(6) 2020, it was reported that the patient had an endoleak of indeterminate origin but is suspected to be proximal type i.Aneurysm growth to 7cm was reported.The physician plans to reintervene but no date has been scheduled.
Additional Manufacturer Narrative
H6: code 213- a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.Images were provided to gore and an evaluation was performed and showed the following: one time-point is available for evaluation: post-implantation cta dated (b)(6) 2020.There appears to be contrast outside the implanted device.Bright contrast can be seen posteriorly at the level of the flow divider.Endoleak origin cannot be confirmed, with available imaging.There appears to be metallic-like densities (possible embolization materials) near the right/posterior sides of the aneurysm sac, distal to the levels where contrast can be visualized in the sac.Maximum diameter of the aaa appears to be 63.4mm x 76.5mm.
Event or Problem Description
The patient was referred to a new physican and it is unknown whether a the patient underwent reintervention.

• 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: 10445572
• Report Number: 2017233-2020-01151
• Device Sequence Number: 2726869
• Product Code: MIH
• UDI-Device Identifier: 00733132622511
• UDI-Public: 00733132622511
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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): 08/27/2020

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: 07/31/2017
• Device Model Number: RLT281218
• Device Catalogue Number: RLT281218
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 08/27/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 82 YR