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

Model Number	PXC181000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), physician and patient should review the risks and benefits when discussing this endovascular device and procedure, including possibility that subsequent interventional or open surgical repair of the aneurysm may be required after initial endovascular repair.
Event or Problem Description
On (b)(6) 2006, the patient underwent treatment of an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis.On an unknown date, aneurysmal disease progression into the left common iliac artery was reportedly identified.According to the physician, an angiogram did not reveal a specific type ib endoleak, and no significant aneurysm enlargement was noted.On (b)(6) 2021, the patient underwent a reintervention procedure whereby an additional gore® excluder® iliac branch component and a gore® viabahn® vbx balloon expandable endoprosthesis were implanted to treat the left common iliac and left internal iliac arteries.The patient tolerated the procedure.
Additional Manufacturer Narrative
H6: code 213 - a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.H6: conclusion code updated.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), physician and patient should review the risks and benefits when discussing this endovascular device and procedure, including possibility that subsequent interventional or open surgical repair of the aneurysm may be required after initial endovascular repair.

• 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
• MDR Report Key: 11753645
• Report Number: 2017233-2021-01929
• Device Sequence Number: 16933441
• Product Code: MIH
• UDI-Device Identifier: 00733132610006
• UDI-Public: 00733132610006
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

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: 07/31/2009
• Device Model Number: PXC181000
• Device Catalogue Number: PXC181000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 07/08/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 80