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

Catalog Number	PLC121200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.H6: code c19 - a review of the manufacturing records indicated the device met pre-release specifications.Code d16 - result is pending for the evaluation of returned device.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
It was reported to gore that on (b)(6) 2024, a patient was to be implanted with a 12 mm x 12 cm gore® excluder® aaa endoprosthesis (excluder device) to treat aortic aneurysm.It was found that the deployment line was broken during the deployment of the iliac leg.The device was partial deployed and couldn't be fully expanded.It was withdrawn through a large sheath and removed from patient.Another excluder device was used complete the procedure successfully.There was no adverse consequence to patient.
Additional Manufacturer Narrative
H6: c19 - the primary reported device failure mode, a broken deployment line resulting in partial device expansion, was confirmed through evaluation of the returned device and the provided device photograph.Inspection of the deployment line routing during engineering evaluation determined the deployment line was routed correctly and unlacing properly during the attempted deployment.The deployment line broke leaving a length of deployment line routed toward the inside of the deployment sleeve through a stitch hole in the sleeve.The end of the broken deployment line was not frayed or stretched, but there is no indication of a cause for the deployment line break that can be assigned to the device manufacturing process.The reported information indicates the physician may have pulled the remaining deployment line before returning the device to gore.The sleeve was deployed several stiches proximal from the most distal stitch hole adjacent the deployment line break, and this is consistent with proper deployment line routing and radial force from the endoprosthesis, and/or potential manipulation of the deployment line outside the patient, continuing the deployment slightly proximal despite the more distal line break.This scenario is possible when the deployment line breaks on the inside of the sleeve during attempted deployment.The reported information indicates resistance was felt during attempted device deployment, but there is no indication the reported resistance was excessive.The confirmed partial expansion is consistent with the broken deployment line, but the specific cause for the broken deployment line could not be established 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: qiong wang ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19790107
• Report Number: 3013164176-2024-02151
• Device Sequence Number: 4197954
• Product Code: MIH
• UDI-Device Identifier: 00733132618712
• UDI-Public: 00733132618712
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2024

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 Catalogue Number: PLC121200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 09/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2024
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 79 KG