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

Model Number	RLT231416
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020, this patient underwent endovascular repair of an abdominal aortic aneurysm using gore excluder aaa endoprosthesis featuring c3 deployment system.The proximal aortic neck was 14mm in diameter and was angulated.A rlt231416 trunk-ipsilateral leg component was used.After implant, infolding was noted due to device over sizing.The case was outside ifu due to anatomical restrictions.On (b)(6) 2020 it was reported that the trunk-ipsilateral leg component had migrated into the aneurysm sac.The physician commented that this was likely due to the device over sizing and infolding, and the cardiac cycle likely pushed the device from its proximal aortic seal zone.Therefore, a reintervention occurred whereby two gore viabahn vbx endoprostheses were implanted in the left and right renal arteries, and a gore excluder aaa endoprosthesis aortic extender (23mm) was implanted proximally in order to obtain proximal seal.The patient tolerated the procedure.

• 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: 10320419
• Report Number: 3007284313-2020-01015
• Device Sequence Number: 3557528
• Product Code: MIH
• UDI-Device Identifier: 00733132622382
• UDI-Public: 00733132622382
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2020

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: 07/28/2022
• Device Model Number: RLT231416
• Device Catalogue Number: RLT231416
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 10/12/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Weight: 72