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

Catalog Number RLT261418J

Device Problem Unintended Movement (3026)

Patient Problem Obstruction/Occlusion (2422)

Event Date 10/23/2023

Event Type  Injury  

Manufacturer Narrative

H.6: code c19: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.H.6: code b20: device remains implanted and therefore not available for direct analysis.H.6.: code a0512: used to capture the unintentional obstruction of the internal iliac artery.H.6.: code d12: according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and/or require intervention include, but are not limited to, endoleak and device/native vessel obstruction and, or occlusion.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.A 18fr gore® dryseal flex introducer sheath was inserted from the left side and a 12fr gore® dryseal flex introducer sheath was inserted from the right side.A proximal of a trunk ipsilateral leg endoprosthesis was deployed from above the bilateral renal arteries.Both renal arteries were covered by the trunk ipsilateral leg as planned because the patient receives dialysis.After a cannulation to the contralateral gate, a contralateral leg endoprosthesis was implanted in the right limb.Then, the ipsilateral leg of the trunk ipsilateral leg was deployed with pushing up in the left limb.It was necessary to push up about 2cm.A touch-up ballooning was performed to each part of the stent grafts.When a non-gore balloon catheter was inserted into the 18fr gore® dryseal flex introducer sheath, the valve of the sheath was broken.It was observed a blood leakage from the valve (amount unknown).A blood transfusion was required.And the balloon was expanded inside the sheath to stop bleeding.Then, an angiography was performed and it revealed a type ii endoleak and an unintentional obstruction of the left internal iliac artery by the ipsilateral leg endoprosthesis.Another gore® dryseal flex introducer sheath (same size) was inserted from the left side.And the ballooning at the distal end of the ipsilateral leg was performed.No additional treatment for the type ii endoleak and the unintentional obstruction of the internal iliac artery was performed.The patient tolerated the procedure.The physician said that he thought the ipsilateral leg was pushed up sufficiently but it wasn't and the sheath was used as usual way.

• 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: kathryn irwin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18156426
• MDR Text Key: 328356850
• Report Number: 3007284313-2023-02892
• 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: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RLT261418J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• Date Device Manufactured: 05/09/2023
• 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 Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Male