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

Model Number	PLC121200
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, this patient underwent elective endovascular treatment for an abdominal aortic aneurysm and was treated with gore¿ excluder¿ aaa endoprostheses.Reportedly, the patient had presented with a very short right common iliac artery.During the procedure, the internal iliac artery was overstented as planned.However, intra-operative imaging revealed that the stent only just covered the internal iliac artery with the physician deciding not to extend the stentgraft at this time.Postoperative imaging performed on (b)(6) 2021, identified that the implanted gore¿ excluder¿ contralateral leg component plc121200 into that short common iliac artery had now migrated proximally resulting in a type 1b endoleak.On (b)(6) 2021, a reintervention was performed and the type 1b endoleak situation was solved by extending the plc121200 component towards distal with an additional endoprosthesis.The patient tolerated the procedure.
Additional Manufacturer Narrative
H6, component code: added code 515.H6, investigation findings: added code 213.H6, investigation conclusions: added code 4315.H6: code 213 - the review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.

• 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: thomas giebing ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11850119
• Report Number: 3013164176-2021-01179
• Device Sequence Number: 11739991
• Product Code: MIH
• UDI-Device Identifier: 00733132618712
• UDI-Public: 00733132618712
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2022

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: 11/19/2023
• Device Model Number: PLC121200
• Device Catalogue Number: PLC121200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 80 KG