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

Model Number	RMT311417
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/16/2021
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.
Event or Problem Description
On (b)(6) 2021, this patient underwent follow-up computed tomography angiography which determined a proximal type i endoleak reported to be caused by a lack of seal and apposition of the graft.The patient is going to be referred to another physician for a possible open surgical procedure, as the patient has a short proximal neck and the physician does not think extending proximally will resolve the endoleak.

• 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: 11758223
• Report Number: 2017233-2021-01937
• Device Sequence Number: 3778376
• Product Code: MIH
• UDI-Device Identifier: 00733132610761
• UDI-Public: 00733132610761
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2021

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: 06/30/2014
• Device Model Number: RMT311417
• Device Catalogue Number: RMT311417
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 78 YR