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

Model Number	RLT311417
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(4) 2021, during an endovascular procedure, when the physician inserted the gore® excluder® aaa endoprosthesis featuring c3 deployment system into a gore® dryseal 18fr sheath, a "pop" was heard.Shortly after that, blood began to leak from the sheath.The physician removed the excluder® delivery system and noticed a metal wire protruding out of the proximal portion of the constrained stent graft.It appeared to be a piece of nitinol wire sticking out between the olive tip and the stent graft.The device and sheath were disposed of at the hospital and not sent back for evaluation.

• 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: 12399441
• Report Number: 3007284313-2021-01564
• Device Sequence Number: 11776233
• Product Code: MIH
• UDI-Device Identifier: 00733132619092
• UDI-Public: 00733132619092
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/02/2023
• Device Model Number: RLT311417
• Device Catalogue Number: RLT311417
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR