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

Model Number	PLC121400
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	12/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021 the patient underwent treatment for an abdominal aortic aneurysm and was implanted with gore ® excluder ® conformable aaa endoprosthesis (cxt261412) and with gore ® excluder ® aaa endoprostheses (plc14100, plc201200, and plc121400).The plc 121400 was extended into the ipsilateral limb on the right side of the patient.A 3cm of overlap was observed between the cxt261412 and the plc121400 at the time of the procedure.A follow up ct scan was performed on an unspecified date and it was observed that the there was no overlap between cxt261412 and the plc121400 endoprostheses.The plc121400 had migrated to the end of the ipsilateral limb on the cxt261412.A type iii endoleak was observed.On (b)(6) 2021 a reintervention was performed in which a plc 161400 was implanted to treat the type iii endoleak.The patient tolerated the procedure and the endoleak was resolved.
Additional Manufacturer Narrative
According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to endoprosthesis component migration and endoleak.
Additional Manufacturer Narrative
H6: code 213 - no device problem found.A review of manufacturing records verified that the lot involved in this complaint 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: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13114616
• Report Number: 3013164176-2021-01283
• Device Sequence Number: 4589801
• Product Code: MIH
• UDI-Device Identifier: 00733132618644
• UDI-Public: 00733132618644
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2021

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: 08/21/2023
• Device Model Number: PLC121400
• Device Catalogue Number: PLC121400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male