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

Model Number	CXT261212
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: patient medications: breo ellipta, alendronate, atorvastatin, losartan, and aspirin.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 field sales associate (fsa) reported the following: on (b)(6) 2022, the patient underwent endovascular treatment of an abdominal aortic aneurysm in zone 9-infrarenal using gore® excluder® conformable aaa endoprostheses.It was reported that the physician positioned the device proximal of the renal arteries and wanted to cannulate the gate.Device was deployed per first step of deployment, and the gate was cannulated.The physician attempted to constrain and reposition the device and pull it distal of renal arteries (planned final position), the device would not slide down.¿at one point it was noticed under imaging that the proximal olive was inside the device and was not actually moving the device.¿ the device was pushed proximal, and the olive was outside of the graft.Under imaging there was a visible ¿unknown wire¿ that was no longer attached to the tip of the delivery system.The physician chose to perform an open conversion and explanted the gore® excluder® conformable aaa endoprosthesis.The patient tolerated the procedure.
Additional Manufacturer Narrative
The device was returned to gore for evaluation.Per the device evaluation performed by engineering, engineering inspected the returned device.The endoprosthesis had been explanted and returned along with the device catheter.The constraining loopholes on the returned endoprosthesis were intact and appeared as expected.There was no damage to the lock pin hole on the leading tip of the device.Given the separated state of the returned components and lack of constraining mechanism, further assessments, or conclusions regarding interactions between components could not be made.The endoprosthesis was cut on the contralateral side during explant.Additionally, the endoprosthesis was bent and appeared bunched down between the body rows.The cause of this could not be determined with the available information.The returned catheter had two kinks in the inner member.The cause of these kinks could not be determined with the available information.There were no holes observed in the inner member and both an engineering provided guidewire and the angulation wire were able to be fully advanced and retracted within their lumens.Based on the findings from the evaluation, the state of the returned device is consistent with the reported observation reported.

• Brand Name: GORE® EXCLUDER® CONFORMABLE 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: 15867117
• Report Number: 3007284313-2022-02234
• Device Sequence Number: 5446509
• Product Code: MIH
• UDI-Device Identifier: 00733132651023
• UDI-Public: 00733132651023
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2023

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: 07/12/2025
• Device Model Number: CXT261212
• Device Catalogue Number: CXT261212
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 11/27/2022
• Supplement Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 59 KG