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

Catalog Number	RLT311413
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to gore that a gore® excluder® aaa endoprosthesis (rlt311413) was used on (b)(6) 2025 for an endovascular aneurysm repair (evar) on a patient with an aneurysm measured 67 mm.This evar case was done in a conical infrarenal neck with significant, circular calcification in both the infrarenal neck and iliacs, and is considered outside instructions for use (ifu).The patient in addition has a bad cardiac condition (recently underwent a transcatheter aortic valve implantation (tavi)) with calcified vessels and has also undergone a percutaneous transluminal angioplasty of both internal iliac arteries and had previous stent placement in proximal part of the superior mesenteric artery.The main device (gore® excluder® aaa endoprosthesis, trunk ipsilateral leg) was placed in position, just distal from a severe chunk of calcium.The positioning was confirmed but the device lacked a bit of apposition in the infrarenal neck.Position was confirmed again after cannulation contralateral gate.The device was released from the delivery system and ballooned before deployment of the contralateral limb.Three additional gore® excluder® aaa endoprosthesis was implanted: one contralateral limb (plc141200 sn (b)(6)) and on the ipsilateral side 2 extensions (pll161407 (b)(6) and plc121200 sn (b)(6)).After ballooning, final angiograph was made and there was a rupture seen in the infrarenal neck.Endo-anchors were placed but the rupture was still visible.A 32mm mdt aortic extender was then implanted for more proximal seal.After this, the rupture is still seen.After checking all the option, the physicians decided to overstent the renal artery for proximal seal to at least solve the rupture.Another gore® excluder® aaa endoprosthesis (aortic extender - pla320400 sn (b)(6)) was used for this.The final angiograph showed no rupture; patient was stable and went to the icu.The physicians concluded that the rupture has nothing to do with the device but is related with the condition of the patient and the very bad condition of the vessels.
Additional Manufacturer Narrative
A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.D10: concomitant medical products: (relevant associated devices used with the device being reported on): gore® excluder® aaa endoprosthesis (contralateral limb - plc141200 sn (b)(6)), gore® excluder® aaa endoprosthesis (iliac extender - pll161407 sn (b)(6)), gore® excluder® aaa endoprosthesis (contralateral limb - plc121200 sn (b)(6)), gore® excluder® aaa endoprosthesis (aortic extender - pla320400 sn (b)(6)).As part of our routine quality procedures, each batch of devices undergoes comprehensive quality control testing and inspections prior to release for distribution.Gore reviewed the manufacturing records associated with the reported lot number and verified that all release criteria had been met.Neither images enabling direct assessment of product performance nor the product itself, which remains implanted, were returned for evaluation.The device instructions for use (ifu) indicate the device is intended to be used in patient's having a non-aneurysmal neck with a neck having minimal calcification.The patient's aortic neck was reported to be conically shaped with heavy calcification, and the reported information confirmed the procedure was outside the device ifu.The cause of the reported lack of vessel wall apposition may be attributed to use of the device outside its indicated anatomical window, and the cause for the vessel rupture is attributed to the patient condition as reported.The gore® excluder® aaa endoprosthesis instructions for use (ifu) were reviewed with respect to the complaint detail for the applicable region and time period, and the following ifu statements were identified in relation to the complaint.Anatomical requirements: ¿ ilio-femoral access vessel size and morphology (minimal thrombus, calcium and / or tortuosity) should be compatible with vascular access techniques and accessories of the delivery profile of a 12 fr-18 fr vascular introducer sheath ¿ an infrarenal, non-aneurysmal aortic neck length of at least 15 mm and an infrarenal aortic neck treatment diameter range of 19-32 mm.¿ for trunk-ipsilateral leg endoprosthesis and aortic extender endoprosthesis: proximal aortic neck angulation = 60° with minimal thrombus and / or calcification ¿ key anatomic elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation, short proximal aortic neck and significant thrombus and / or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.The us clinical studies quantify significant thrombus as thrombus = 2 mm in thickness and / or = 25% of the vessel circumference in the intended seal zone of the aortic neck.Irregular calcium and / or plaque may compromise the fixation and sealing of the implantation sites.Adverse events that may occur and / or require intervention or additional intraoperative procedure time include but are not limited to: aneurysm rupture and death.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 have not 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.

• 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: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22084188
• Report Number: 3007284313-2025-03998
• Device Sequence Number: 12494130
• Product Code: MIH
• UDI-Device Identifier: 00733132619078
• UDI-Public: (01)00733132619078(17)261108
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2025

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 Catalogue Number: RLT311413
• 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: 05/08/2025
• Initial Report FDA Received Date: 05/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2023
• 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
• Patient Age: 76 YR
• Patient Sex: Female