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

Catalog Number RLT261418J

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/12/2024

Event Type  malfunction  

Manufacturer Narrative

H.6 investigation findings code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H.6.Type of investigation code b01 and investigation findings code c24: the device evaluation showed the following: engineering removed the handle covers and the spine was examined.The manifold assembly contained dried blood.The septum appeared to be intact with no obvious damage.The glue ports were inspected and appeared to be filled with glue and cured.Purple dyed water was pressurized through the septum into the manifold area to determine the location of the leakage.A small amount of purple dyed water was observed externally, towards the nose of the manifold.However, due to small amount, engineering could not identify the source of dyed water.Based on the findings from this evaluation, the observation ¿small amount of blood leakage from the delivery catheter handle (near the junction of the shaft and handle) was observed¿ was confirmed.The likely cause for the reported small amount of blood leakage could not be determined with the available information.H.6 investigation conclusion code d15: there is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code ¿d15: cause not established¿ is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or 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 Description

The following information was reported to gore: on (b)(6) 2024, this patient underwent an endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.During the procedure, after deploying a trunk - ipsilateral leg endoprosthesis proximal part, a small amount of blood leakage from the delivery catheter handle (near the junction of the shaft and handle) was observed, so the plan to implant the contralateral leg first was changed, and the deployment of the trunk - ipsilateral leg endoprosthesis was prioritized.The ipsilateral leg was deployed before cannulating to the contralateral gate, and the deployment completed without further reported issues.No transfusion was performed.The patient tolerated the procedure.Reportedly, the blood leakage was dripping at regular intervals.According to the fsa, the deployment of the trunk was hurried due to the blood leaking.

Manufacturer Narrative

H.6.Component code updated to g04044.

• 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: bryce wargin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19076687
• MDR Text Key: 339775528
• Report Number: 3007284313-2024-03164
• 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: 04/12/2024

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: RLT261418J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2023
• 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: 81 YR
• Patient Sex: Female