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

Catalog Number RLT261218J

Device Problem Material Separation (1562)

Patient Problem Aneurysm (1708)

Event Date 03/24/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.A gore® dryseal flex introducer sheath (dsf) was used for access.The 16fr dsf sheath was inserted from left femoral artery.When the trunk-ipsilateral leg component was inserted the dryseal valve, the valve teared.The sheath was replaced with another 16fr dsf sheath but same event occurred.The physician decided to replace the trunk-ipsilateral leg component with another same size one, and the sheath was upsized to 18fr dsf sheath.The attempt was successful.During the procedure, it was observed that the contralateral leg hole was compressed due to aortic angulation; hence, ballooning was performed.The final angiography revealed a small proximal type i endoleak remained.The physician elected to monitor it and the procedure was completed.The patient tolerated the procedure.It was reported that the trailing end of the leading olive appears to get fray a little.No customer response is required.Three devices were returned to us for analysis and showed the following: device - (b)(4).Based on the findings from this evaluation, they physician¿s observation that the valve teared when inserting the trunk-ipsilateral leg component was not confirmed because engineering is unable to determine when the lock pin became dislodged.Based on the findings from this evaluation, the physician¿s observation that the trailing end of the leading olive appeared to fray was not confirmed.The likely cause that when the trunk-ipsilateral leg component was inserted the dryseal valve, the valve tore, could not be determined with the available information.Device - (b)(4).The root cause for the valve leaks was tears in the film tubes.The root cause of the film tube tears could not be determined.Device - (b)(4).The root cause for the valve leaks was tears in the film tubes.The root cause of the film tube tears could not be determined.

Manufacturer Narrative

Device was returned for evaluation.(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.

• 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15026260
• MDR Text Key: 296248549
• Report Number: 3007284313-2022-02035
• 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
• Report Date: 07/15/2022

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: RLT261218J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male