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

Catalog Number	PLC181000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Paraplegia (2448)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B7: patient medical history includes but is not limited to: htn, hypercholesteroemia, sleep apnea, histor of tia.D10: patient medications include but are not limited to: amlodipine, atorvastatin, flexeril, losartan, metoprolol succinate er, naproxdn tablet, spironolactone, tadalafil.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
On (b)(6) 2024, this patient underwent endovascular treatment of a zone 5 descending thoracic aortic aneurysm and was implanted with gore® excluder® thoracoabdominal branch endoprosthesis (tambe).It was reported that during implant of the gore® excluder® iliac branch component the device was almost completely pulled out of the 3cm overlap zone during removal of the device delivery system.A gore® tag® conformable thoracic stent graft was implanted to bridge any gap and reline the area.During this procedure, gore® viabahn® vbx balloon expandable endoprosthesis were used as branch devices in the superior mesenteric artery, celiac artery, right and left renal arteries.A gore® tri lumen catheter was used to gain through and through wire access to the branch arteries.The procedure was completed with good technical results.The patient tolerated the procedure.On (b)(6) 2024, it was reported that the patient awoke and had no feeling in his legs.The patient underwent placement of a spinal drain.The physician does not know what caused the paraplegia.The patient is being monitored in the intensive care unit (icu) and was reported to have started regaining movement in his right leg and can move his left foot.

• 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19767599
• Report Number: 3013164176-2024-02143
• Device Sequence Number: 8778047
• Product Code: MIH
• UDI-Device Identifier: 00733132618743
• UDI-Public: 00733132618743
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 07/17/2024

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 Catalogue Number: PLC181000
• 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: 06/26/2024
• Initial Report FDA Received Date: 07/17/2024
• Date Device Manufactured: 03/21/2024
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 121 KG