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

Catalog Number	RLT231414
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	11/18/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
As it is unknown which device(s) is directly implicated in this death event, the following device(s) will also be included in this report: catalog #plc141200/ serial # (b)(6)/ udi #(b)(4).Catalog #plc141000/ serial # (b)(6)/ udi #(b)(4).According to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and / or require intervention include death, arterial or venous thrombosis, occlusion of device or native vessel, single or multiple vessels.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
The following was reported to gore: on (b)(6) 2024, the patient underwent an endovascular procedure utilizing the gore® excluder® thoracoabdominal branch endoprosthesis (tambe) and gore® excluder® aaa endoprosthesis (rlt and 2 plcs) in zone 5.Prior to the procedure, the physician addressed the patient's left renal artery that was already occluded.A gore® viabahn® vbx balloon expandable endoprosthesis (vbx device/stent) was deployed into the renal portal that was followed by an amplatzer plug.During the procedure, there was not an adequate landing zone in the patient¿s celiac artery.There was a short branch from the left gastric artery that branched off the splenic artery.To achieve a seal into the celiac artery, the physician plugged the splenic artery and coiled the left gastric artery.A vbx device was then implanted into the patient¿s hepatic artery.Additional vbx devices were implanted in the celiac artery and superior mesenteric artery with no issues.On (b)(6) i-cast stent was implanted in the right renal artery (rra) due to existing high-grade stenosis.During the procedure, two vbx devices were deployed within the rra.As reported, procedure went smoothly and the patient tolerated the procedure.After procedure completion, a non-contrast ct imaging showed all devices were widely patent with no compression or stenosis noted.On (b)(6) 2024, the nursing staff changed the patient's bedding and the patient moved on her own with no issues.However, when the patient was moved back into bed, her blood pressure dropped into the 50¿s when lying flat in bed.The patient coded and advanced cardiac life support (acls) was performed.After resuscitation, the patient was intubated, and it was also noted that she had aspirated.The patient was transferred for cta scan of the chest.Abdomen and pelvis showed irregular response of aorta secondary to cardiac dysfunction.The patient had rib fractures noted on the ct after acls.The vbx stents in the right renal artery were also crushed.As reported, the physician believes that due to cardiac event and extended low / minimal blood pressure, the patient's visceral arteries (celiac, hepatic, sma, and right renal artery) all presented as thrombosed/occluded, along with the tambe device, vbx device, and excluder devices.The patient remained intubated post ct scan and expired sometime in the morning.The right renal artery vbx stents were likely crushed while trying to resuscitate the patient.The primary cause of the patient's death is unknown.It is also unknown if the patient had sensitivity to heparin as testing was not done prior to procedure.
Additional Manufacturer Narrative
Added g3/g4, h1/h2, 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; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: monique nwanze ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21883810
• Report Number: 3007284313-2025-03919
• Device Sequence Number: 11645247
• Product Code: MIH
• UDI-Device Identifier: 00733132622375
• UDI-Public: (01)00733132622375(17)250412
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

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: 04/12/2025
• Device Catalogue Number: RLT231414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Death
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 65 KG