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

Model Number	RLT261418
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not returned as it remains implanted.(b)(4).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 a kink and narrowing of the ipsilateral leg of a gore® excluder® aaa endoprosthesis was observed through the final angiography during the implant on (b)(6) 2021.The same kink and narrowing was also observed during the one month follow-up but was not seen as an issue.On the one year ct control the physician decided to reinforce the stent graft in the narrow part with a gore® viabahn® vbx balloon expandable endoprosthesis (bxa115901e) in the near future.The patient remains symptom free.
Additional Manufacturer Narrative
A review of the manufacturing records indicated the lot met all pre-release specifications.The imaging evaluation performed by a clinical imaging specialist showed the following: the device takes a 90 degree bend and from an ap projection in the angiogram, the viewer ascertains the ¿flattened¿ 9-12mm diameter.When visualized on the ct scan, the additional perspective shows the area/diameter decrease in the orthogonal plane.There is likely no change from the angiogram.Ct scan: area within constrained ipsi limb ~ 66mm, ~ 9.18mm average diameter (inner -inner) area within the unconstrained limb ~ 169mm ~ 14.7mm (inner ¿ inner) angiogram: there are no markers to calibrate the software measurement.If 14.5mm = 62.6, then 38.5 units = 8.9mm this reflects the average diameter of 9.1mm recorded on the ct scan dated 7/29/2021.No device problem can be detected from the images provided.With the information reported to gore this investigation is considered complete, the cause of the complaint was unable to be determined.H6: updated investigation findings code to c19 - no device problem found.Code c21 is no longer applicable.Updated investigation conclusions code to d15 - cause not established.Code d16 is no longer applicable.It was additionally reported by the physician that he is not considering this as a malfunction of device.

• 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: 15437483
• Report Number: 3007284313-2022-02115
• Device Sequence Number: 12223721
• Product Code: MIH
• UDI-Device Identifier: 00733132622474
• UDI-Public: 00733132622474
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 11/30/2022

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
• Device Expiration Date: 02/16/2024
• Device Model Number: RLT261418
• Device Catalogue Number: RLT261418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2021
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 109 KG