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

Model Number	RLT281218
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Shock (2072)
Date of Event	03/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.Due to no device and imaging return, an investigation could not be performed.Therefore, the cause of the reported complaint can not be determined.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2021, this patient underwent endovascular treatment using 28mm x 12mm x 18cm gore® excluder® aaa endoprosthesis(excluder device) for abdominal aortic aneurysm.After excluder device was advanced through lunderquist guidewire, the blood leakage from c3 handle was observed.The total amount of blood loss was about 800-1000ml.The patient's hemoglobin decreased by 2g and shock occurred.The patient's blood pressure dropped significantly from 130/90 to 90/60.Additional fluids, blood transfusion and vasopressor therapy were performed.There was no hurried deployment.The procedure was continued without reported issues per original plan.The patient tolerated the procedure and recovered well after the operation.
Additional Manufacturer Narrative
Updated g1, h6.

• 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 PHOENIX 2 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: pixie xi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11683896
• Report Number: 3007284313-2021-01394
• Device Sequence Number: 16897899
• Product Code: MIH
• UDI-Device Identifier: 00733132622511
• UDI-Public: 00733132622511
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

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: 10/28/2021
• Device Model Number: RLT281218
• Device Catalogue Number: RLT281218
• 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: 04/13/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PLC231200 PLC141000 DSF1633 DSF1433.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 75 KG