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

Model Number	PLC161000
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2003 the patient underwent endovascular treatment and was implanted with a gore® excluder® bifurcated endoprostheses (pcc121200 and pct261216).The patient tolerated the procedure.On (b)(6) 2021 the patient was undergoing treatment for a type 1b endoleak with an unknown onset date.The gore® excluder® aaa endoprosthesis contralateral leg endoprosthesis (plc161000) was inserted into the patient and was positioned in the patients anatomy for deployment.As reported the deployment line would not pull and felt like it was stuck, and the endoprosthesis would not deploy.The device was removed over the guidewire and a new contralateral endoprosthesis device was inserted and employed without incident.The endoleak was successfully resolved and the patient tolerated the procedure.
Additional Manufacturer Narrative
213, no device problem found - a review of manufacturing records verified that the lot involved in this event met all pre-release specifications.10, testing of actual/suspected device - device was returned for evaluation.170, manufacturing process problem identified - the device in question was manufactured prior to the implemented corrective actions associated with this type of event.25, cause traced to manufacturing - the device in question was manufactured prior to the implemented corrective actions associated with this type of event.

• 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: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13097455
• Report Number: 3013164176-2021-01280
• Device Sequence Number: 11829060
• Product Code: MIH
• UDI-Device Identifier: 00733132618668
• UDI-Public: 00733132618668
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P02004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2022

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: 09/24/2023
• Device Model Number: PLC161000
• Device Catalogue Number: PLC161000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/27/2021
• Supplement Date Received by Manufacturer: 12/27/2021
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2020
• 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
• Patient Age: 83 YR
• Patient Sex: Male