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

Model Number	PLC121000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/20/2022
Type of Reportable Event	Serious Injury
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 (b)(6) 2022, the patient was implanted with two gore® excluder® aftermarket devices, as well as the gore® excluder® thoracoabdominal branch endoprosthesis (tambe device).A gore® dryseal flex introducer sheath was used for the procedure.The patient was being treated for an aortic aneurysm involving the visceral vessel(s).It was reported that on (b)(6) 2022, follow up images revealed a left external iliac artery dissection.No treatment is planned at this time.
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: pll161207/ 24521890, udi (b)(4).Patient medications: aspirin, gabapentin, acetaminophen, heparin, morphine, clopidogrel, hydrocodone, tramadol, and ibuprofen.
Event or Problem Description
Additional information obtained from study site, there was not an existing dissection in the left external iliac artery (during tambe procedure).The dissection in the left external iliac artery originating distal to the plc12100/(b)(6) device.The dissection in the left external iliac artery originating distal to the pll161207/(b)(6) device.It is unknown if the dsf1233/(b)(6) contributed to the dissection during the initial procedure.The event is ongoing.
Additional Manufacturer Narrative
Addition section h code d12-the gore® excluder® aaa endoprosthesis instructions for use (ifu) states that adverse events that may occur and/or require intervention include, but are not limited to vascular trauma (e.G., ilio-femoral vessel dissection).

• 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: 14698978
• Report Number: 3013164176-2022-01402
• Device Sequence Number: 17801306
• Product Code: MIH
• UDI-Device Identifier: 00733132618613
• UDI-Public: 00733132618613
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2022

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: 12/13/2024
• Device Model Number: PLC121000
• Device Catalogue Number: PLC121000
• 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: 05/19/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 10/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 41 KG
• Patient Race: Black Or African American