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

Model Number	CXT201412
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/22/2022
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, aneurysm enlargement.
Event or Problem Description
On (b)(6) 2022, this patient underwent endovascular treatment for an abdominal aortic aneurysm measuring 5.5 cm in diameter and was implanted with gore® excluder® conformable aaa endoprostheses.The patient tolerated the procedure.On (b)(6), 2022, the physician reported that the patient had a persistent type ii endoleak and the aneurysm measured approximately 6.2 cm in diameter.The physician reported the device looked good.The physician based on the patient¿s age is planning to either open the patient and either remove the device off the lumbar's or remove the device and sew off the lumbar's and place an open graft.The physician reported this is in despite of nothing being wrong with the device, it hasn't moved.There is no type 1 endoleak type 3, no type 4.So not completely clear, there is no failure point the physician can see.Physician reports the patient has a very angled neck exceeding; or right at a 60 degree angle.
Event or Problem Description
On (b)(6) 2022, the patient underwent reintervention wherein they opened the patient, clamped the aorta above the device and converted the patient to open surgical repair and explanted the devices.No endoleak was able to be confirmed, the physician reported 4mm enlargement of the aneurysm.Patient tolerated the procedure.The explanted devices were discarded at the site.

• 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 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14278177
• Report Number: 3007284313-2022-01884
• Device Sequence Number: 6265538
• Product Code: MIH
• UDI-Device Identifier: 00733132650996
• UDI-Public: 00733132650996
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 08/12/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/29/2023
• Device Model Number: CXT201412
• Device Catalogue Number: CXT201412
• 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: 04/22/2022
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 08/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female