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

Catalog Number	RLT261214
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It as reported to gore that a gore® excluder® aaa endoprosthesis was implanted on (b)(6) 2015 in order to treat an abdominal aortic aneurysm.On an unknown date in (b)(6) 2022, an endograft infection was discovered and the patient received laparotomy with drainage of the abscess on (b)(6) 2022.Due to the recurrent abscess, the patient received antibiotic therapy on an unknown date in (b)(6) 2023.No aneurysm enlargement has been observed during the follow-up controls.
Additional Manufacturer Narrative
B3: the date of event is unknown.Therefore, the date of the first reintervention is used as date of event.D10: concomitant medical products: (relevant associated devices used with the device being reported on): gore® excluder® aaa endoprosthesis (contralateral leg pxc121200, sn (b)(6)), gore® excluder® aaa endoprosthesis (aortic extender pla260300, 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.Sterilization records is being reviewed.H3 other code and h6 b20: the device remains implanted and therefore no product evaluation has been performed.The patient referenced in this event file is enrolled in a post market prospective observational cohort registry designed to obtain data on device performance and clinical outcomes of patients treated with gore endovascular aortic products through the global registry for endovascular aortic treatment (great).Medidata rave® is the clinical study database (csd), capturing the data through the grt 10-11 module.The above information was obtained from the csd.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.
Additional Manufacturer Narrative
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 and sterilization records associated with the reported lot number and verified that all release criteria had been met.Based on the incident description and the subsequent investigation, no further information was provided to gore, we are unable to determine the cause of this incident and assign a root cause.Updated h6: code b15 was inadvertently entered and should be removed.Updated investigation findings code to c24, code c21 is no longer applicable.Updated investigation conclusions code to d15, code d16 is no longer applicable.

• 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: 20598132
• Report Number: 3007284313-2024-03561
• Device Sequence Number: 20465167
• Product Code: MIH
• UDI-Device Identifier: 00733132622412
• UDI-Public: 00733132622412
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2024

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 Expiration Date: 04/05/2018
• Device Catalogue Number: RLT261214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Other
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 75 KG