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

Model Number	CXT201212
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/29/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Code 22: 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: occlusion of device or native vessel, rupture.As gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: pll161207/22773241.
Event or Problem Description
On (b)(6) 2021, this patient underwent endovascular treatment for aortic occlusive disease and was implanted with gore® excluder® conformable aaa endoprostheses.The trunk ipsilateral leg component deployed correctly but was positioned slightly higher than intended with partial coverage of the ostium of a renal artery.The device was reconstrained and the physician attempted to reposition but struggled with trying to reposition the cxt and chose to leave it as is and implant a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) covered stent in one of the renal arteries to ensure good flow.During post-dilitation of the vbx with a coda balloon catheter the renal artery was ruptured due to believed over-inflation of the balloon.The patent expired intra-procedure, a cause of death was not provided.
Additional Manufacturer Narrative
H6: added additional conclusion code.
Additional Manufacturer Narrative
Corrected g4 and h6.

• Brand Name: GORE® EXCLUDER® CONFORMABLE 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: 12334625
• Report Number: 3007284313-2021-01550
• Device Sequence Number: 14159621
• Product Code: MIH
• UDI-Device Identifier: 00733132650989
• UDI-Public: 00733132650989
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P200030
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2022

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: 02/26/2023
• Device Model Number: CXT201212
• Device Catalogue Number: CXT201212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 07/29/2021; 03/29/2022
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 10/13/2021; 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2020
• 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; Death
• Patient Age: 59 YR
• Patient Sex: Female