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

Model Number	RLT231218
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, this patient underwent endovascular treatment of an abdominal aortic aneurysm and a unilateral right common iliac artery aneurysm and was implanted with gore® excluder® aaa endoprostheses featuring c3® delivery system and gore® excluder® iliac branch endoprostheses.The patient tolerated the procedure.On an unknown date the patient the patient complained of left side claudication.On an unknown date, follow computed tomography (ct) determined compression of the left ipsilateral limb at the level of the flow divider.On (b)(6) 2022, the patient underwent reintervention and angiojet thrombectomy was performed followed by placement of a gore® viabahn® vbx balloon expandable endoprosthesis in the area of compression.Intravascular ultrasound (ivus) was used to confirm patency of the graft.The patient tolerated the procedure.
Additional Manufacturer Narrative
The device evaluation was performed only based on what was reported to gore as the device was not returned for analysis and imaging of the reported compression were unavailable.Without a physical device or images, the physician¿s observation that ¿compression of the left ipsilateral limb at the level of the flow divider¿, could not be evaluated.The likely cause for the reported compression at the flow divider could not be determined with the available information.H6: code 213: a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.
Additional Manufacturer Narrative
Added h6: conclusion code.

• 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13373907
• Report Number: 3007284313-2022-01761
• Device Sequence Number: 19699434
• Product Code: MIH
• UDI-Device Identifier: 00733132622351
• UDI-Public: 00733132622351
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/21/2023
• Device Model Number: RLT231218
• Device Catalogue Number: RLT231218
• 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: 01/22/2022
• Supplement Date Received by Manufacturer: 01/22/2022; 05/02/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 03/16/2022; 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2020
• 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; Other; Required Intervention
• Patient Sex: Male