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

Model Number	RLT281418
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: (b)(4).
Event or Problem Description
The field sales associate (fsa) reported the following: on (b)(6) 2021, this patient underwent an endovascular repair for an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses and an iliac aortic aneurysm treated with a gore® excluder® iliac branch endoprostheses.The patient tolerated the procedure.It was reported that on (b)(6) 2022, there was a reintervention (adverse event is unknown).A (b)(4) was implanted to extend one of the already implanted devices.The fsa that attended the procedure was covering for another fsa and did not report this reintervention to product surveillance.On (b)(6) 2022, a different fsa reported that he was in a case and ran into the implanting physician.The physician stated that this patient had an infection, and all devices were explanted (date of explant is unknown) and an open conversion was performed.The infection was in the implanted device area, but it is unknown what the cause of the infection was.The physician did not attribute the infection to the gore devices or procedure.The explant occurred at a different hospital and with a different vascular physician.The patient tolerated the explant procedure.The exact date of the event is unknown, however, since the complaint was reported in (b)(6) 2022, the date of event will be logged as on (b)(6) 2022.
Additional Manufacturer Narrative
Addition additional devices implanted and/or related to this event: (b)(4).
Additional Manufacturer Narrative
Addition the review of the sterilization paperwork verified that these lots 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13896520
• Report Number: 3007284313-2022-01835
• Device Sequence Number: 4391942
• Product Code: MIH
• UDI-Device Identifier: 00733132622559
• UDI-Public: 00733132622559
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2022

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: 07/13/2024
• Device Model Number: RLT281418
• Device Catalogue Number: RLT281418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 03/10/2022; 03/10/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 03/31/2022; 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• 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; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male