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

Catalog Number RLT281412J

Device Problems Difficult to Remove (1528); Difficult or Delayed Activation (2577)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/26/2023

Event Type  malfunction  

Manufacturer Narrative

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 Description

The following was reported to gore: on (b)(6) 2023, the patient underwent an endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.The proximal of a trunk ipsilateral leg endoprosthesis was deployed.However, it looked that the stent graft was not complete expansion and not aligned a vessel wall of a proximal neck.Therefore, the constraining mechanism was used and the proximal of the trunk ipsilateral leg endoprosthesis was constrained and repositioned more proximally.Then, the proximal of the trunk ipsilateral leg endoprosthesis was reopened.After a canulation to the contralateral gate was performed and a contralateral leg was implanted, during the transparent knob was attempted to remove, it seemed that the proximal of the trunk ipsilateral leg looked like constrained and it was not able to pull the transparent knob completely with resistance.Upon the constraining dial was turned tentatively, the proximal of the trunk ipsilateral leg was constrained.So, it was wondered the constraining mechanism was not separated from the leading olive.The line of the lock pin which was seen from the transparent knob was pulled and removed, then the transparent knob was pulled, the constraining loop was able to be removed.It was reported that the constraining loop was not broken.The proximal of the trunk ipsilateral leg was seemed not expanded completely due to the patient anatomy.The touch-up balloon was performed, then it was resolved.There was no endoleak and the procedure was concluded.The patient tolerated the procedure.

Manufacturer Narrative

H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device evaluation showed the following: engineering examined the returned components.Each component appeared to be intact with no obvious damage.No abnormalities were noticed.The screw knob was able to be turned clockwise and counterclockwise, and the guide nut moved in the appropriate respective directions.The compression spring was in the proper position in the trough of the bottom screw housing.The glue channels located on the top screw housing and on the guide nut appeared to be filled with glue and cured.The lock pin was visible on both sides of the anchor bead in the top screw housing.The constraining loop was visible on both sides of the anchor bead in the guide nut.Based on the findings of this evaluation, the physician¿s observation that ¿it seemed that the proximal of the trunk ipsilateral leg looked like constrained and it was not able to pull the transparent knob completely with resistance¿ could not be confirmed.Based on the findings of this evaluation, the physician¿s observation that ¿the proximal of the trunk ipsilateral leg was seemed not expanded completely due to the patient anatomy¿ could not be confirmed as clinical images were not available for evaluation.The likely cause for the reported observation of ¿the proximal of the trunk ipsilateral leg looked like constrained during the transparent knob was attempted to remove and it was not able to pull the transparent knob completely with resistance" could not be determined with the available information.Emdr section h6, codes c19, d15 updated to reflect results of investigation.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: 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: asami aizawa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18567663
• MDR Text Key: 333540806
• Report Number: 3007284313-2024-03015
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: RLT281412J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 02/20/2024
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male