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

Model Number	PLC201400
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	03/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020, the patient was treated for an abdominal aortic aneurysm.A gore® excluder® aaa endoprosthesis featuring c3® delivery system and a gore® excluder® aaa endoprosthesis plc201400 were implanted.On (b)(6) 2020, the patient reported a cold right leg.It was reported that thrombus was present in the plc201400.A gore® excluder® aaa endoprosthesis pll161207 was implanted and ballooned, which resolved the issue.The patient tolerated the procedure.
Additional Manufacturer Narrative
H6: code 213 - the review of the manufacturing paperwork verified that this lot met all pre-release specifications.H6: code 22 ¿ according to the gore® excluder® aaa endoprosthesis instructions for use, adverse events with may occur and/or require intervention including, but not limited to, occlusion of device or native vessel.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9973108
• Report Number: 3013164176-2020-00056
• Device Sequence Number: 2897191
• Product Code: MIH
• UDI-Device Identifier: 00733132618552
• UDI-Public: 00733132618552
• 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
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2020

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: 01/14/2023
• Device Model Number: PLC201400
• Device Catalogue Number: PLC201400
• Device Lot Number: 21565776
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 06/05/2020
• 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: Required Intervention
• Patient Age: 73 YR