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

Model Number	PLC141000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: plc201400/ (b)(4), udi (b)(4), plc141000/ (b)(4), udi (b)(4) and plc231400/ (b)(4), udi (b)(4).
Event or Problem Description
The following information was reported to gore through the pivotal study for the gore® excluder® thoracoabdominal branch endoprosthesis (tambe device): on an unknown date, the patient was implanted with several gore® excluder® after market devices, as well as the gore® excluder® thoracoabdominal branch endoprosthesis (tambe device).It was reported that on (b)(6) 2022, the patient presented with femoral compartment syndrome (unknown if it was on the left or right side).The physician reintervened and performed a fasciotomy.The patient tolerated the reintervention procedure.
Additional Manufacturer Narrative
Per md24757, section 6, worldwide adverse event guidance no reportable death, serious injury, or malfunction occurred; this event is deemed not reportable in the united states (ref: 21cfr 801.4 & 803.3).Per md24757, section 6, worldwide adverse event guidance no reportable death, serious injury, or malfunction occurred; this event is deemed not reportable in japan (japan guidelines for deficiency reporting).Per md24757, section 6, worldwide adverse event guidance this event meets the criteria of a death, serious injury, or malfunction and is reportable in the united states and japan.The physician would not provide any additional patient details.Additional investigation determined no product problem or deficiency caused or contributed to an adverse event/incident for the patient; the initial medwatch was submitted in error, and is hereby retracted.

• 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: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14575797
• Report Number: 3013164176-2022-01392
• Device Sequence Number: 6177260
• Product Code: MIH
• UDI-Device Identifier: 00733132618637
• UDI-Public: 00733132618637
• Combination Product (Y/N): N
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2022

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: 02/16/2025
• Device Model Number: PLC141000
• Device Catalogue Number: PLC141000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male