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

Model Number	PXT231416
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
On (b)(6) 2007, the patient was treated for an abdominal aortic aneurysm.The physician implanted two gore® excluder® aaa endoprostheses, one in the lcia and one in the rcia.The patient tolerated the procedure.On (b)(6) 2022, the physician performed a reintervention, after follow up showed aneurysm enlargement on both sides.He believes disease progression caused the enlargement, as no endoleaks were found.He implanted two gore® excluder® aaa endoprostheses and a gore® excluder® iliac branch endoprosthesis, as well as embolizing the lcia.The patient tolerated the procedure.Images were received and evaluated.
Additional Manufacturer Narrative
H.6.Type of investigation code 4118 updated to code 3331 with completion of phr review h.6.Investigation findings: investigation findings code updated to code 213 as a result of the completion of a dhr review.H.6.Investigation conclusions: code 11 updated to code 4315.An evaluation of returned images was performed.The evaluation stated: there appears to be an excluder approximately 10-15mm distal to the lowest renal artery.Note: the implanted endograft is fully apposed to the aorta @15mm distal to the lowest renal artery.There appears to be approximately 8mm of seal.There is no contrast visualized outside the graft proximally.There is no evidence of contrast within the distal abdominal aorta indicating a type 1b endoleak.There is ~59mm from the end of r ipsi limb to the r hypogastric artery.There is approximately 62mm from the end of the contralateral limb to the l hypogastric artery.

• 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 SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14252073
• Report Number: 2953161-2022-01133
• Device Sequence Number: 5015353
• Product Code: MIH
• UDI-Device Identifier: 00733132610150
• UDI-Public: 00733132610150
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

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: 07/31/2010
• Device Model Number: PXT231416
• Device Catalogue Number: PXT231416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 67 KG