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

Model Number	CXA260005
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, this patient underwent endovascular treatment for abdominal aortic aneurysm and was implanted with gore® excluder® conformable aaa endoprosthesis.Intraprocedure imaging showed a slight type i endoleak and a gore® excluder® conformable aortic extender component was placed to extend coverage.Conclusion angiography showed an unknown artifact above the renal arteries.The endoleak was resolved and the procedure was concluded.The patient was transferred to another hospital wherein they reintevened and placed stents in the superior mesenteric artery and the left renal artery.They were not able to stent the right renal artery.The patient tolerated the procedure and is due to be discharged tomorrow.
Additional Manufacturer Narrative
Patient medical history includes but is not limited to: pain, acute arthritis, muscle cramp, right artificial hip joint, artificial knee joint, bilateral renal artery aneurysm and repair, major depressive disorder.Patient medications include but are not limited to: aspirin, hydrochlorothiazide, amlodipine besylate, carvedilol, finasteride, gabapentin, fexeril, potassium, clotrimazone cream.Images were provided to gore for evaluation and showed the following: one time-point available for evaluation: post-implantation cta dated 10/19/2021.There appears to be a stent in the celiac artery.Device markers appear to show there is a gore® excluder® endoprosthesis implanted and an aortic extender stent graft conformable implanted.There appears to be streak artifact throughout the imaging due to an unknown metallic density proximal to the level of the celiac origin outside the aorta.The splenic artery appears at the distal end of the metallic density and appears to be patent.Streak artifact may also be caused by contrast in the bladder and prosthetic hip replacements, bilaterally.Therefore, imaging is very poor quality.The stent in the celiac artery appears to extend into the hepatic artery.No other densities in the aorta can be confirmed with available imaging.
Additional Manufacturer Narrative
Imaging was provided to gore for evaluation and showed the following: one time-point available for evaluation: post-implantation cta dated (b)(6) 2021.There appears to be a stent in the celiac artery.Device markers appear to show there is a gore® excluder® endoprosthesis implanted and an aortic extender stent graft conformable implanted.There appears to be streak artifact throughout the imaging due to an unknown metallic density proximal to the level of the celiac origin outside the aorta.The splenic artery appears at the distal end of the metallic density and appears to be patent.Streak artifact may also be caused by contrast in the bladder and prosthetic hip replacements, bilaterally.Therefore, imaging is very poor quality.The stent in the celiac artery appears to extend into the hepatic artery.No other densities in the aorta can be confirmed with available imaging.The device was returned to gore for analysis by engineering and showed the following: there is no damage associated with the returned aortic extender handle assembly, catheter, and leading tip.There were no other observations with the examined components that could have contributed to the event description.Based on the engineering evaluation of the returned device, the reported event could not be confirmed.In addition, the root cause of the unknown artifact above the renal arteries could not be determined with the available information.

• 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: 12797586
• Report Number: 3007284313-2021-01652
• Device Sequence Number: 14882625
• Product Code: MIH
• UDI-Device Identifier: 00733132650941
• UDI-Public: 00733132650941
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 02/24/2022

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: 09/02/2023
• Device Model Number: CXA260005
• Device Catalogue Number: CXA260005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 10/19/2021; 10/19/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 12/17/2021; 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2020
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 109 KG