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

Model Number	RLT281418
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient medications: aspirin, atorvastatin calcium, lisinopril, metoprolol succinate er, clopidogrel bisulfate, hydrochlorothiazide, tamsulosin and ezetimibe.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) 2023, the patient was implanted with a gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported that while retracting the delivery catheter of the gore® excluder® aaa trunk-ipsilateral leg endoprosthesis through the valve of the gore® dryseal flex introducer sheath (18fr) the olive became dislodged/separated.The olive was outside the patient but wedged in the valve.The physician was able to retrieve the olive with no issue.Reportedly there was no restrictions while advancing or retracting the delivery catheter.The patient tolerated the procedure.
Additional Manufacturer Narrative
The device was returned to gore for evaluation.The device evaluation showed visual examination of the delivery catheter kinked in several locations likely due to shipping of the device back to gore.Engineering observed that the leading olive and polyimide separated from catheter.The separated portion of the polyimide measured approximately 8cm.Engineering observed evidence of the polyimide material in the trailing olive.The leading end is detached from the rest of the delivery catheter.The separated polyimide appears to have been fractured.The leading olive is still attached to the polyimide and appears to be intact with no visible defects.Based on the findings from this evaluation, the observations that ¿the olive became dislodged/separated¿ was confirmed.The separation appears to be a fracture of the polyimide at the mid-olive transition of the catheter.The likely cause for the leading olive and polyimide separated from catheter was unable to be determined with the available information.

• 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: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17260301
• Report Number: 3007284313-2023-02594
• Device Sequence Number: 7911689
• Product Code: MIH
• UDI-Device Identifier: 00733132622559
• UDI-Public: 00733132622559
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2023
• Device Model Number: RLT281418
• Device Catalogue Number: RLT281418
• 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: 06/09/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2020
• 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: Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 98 KG