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

Catalog Number PLC141200J

Device Problem Insufficient Information (3190)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 11/15/2022

Event Type  Injury  

Event Description

The following information was reported to gore: on (b)(6) 2022, this patient underwent an endovascular treatment for an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.During insertion of gore® dryseal flex introducer sheath (dsf1833) through the right femoral artery, resistance was felt at the right external iliac artery, and it could not be advanced anymore.An attempt was made to advance rlt311417j alone to just under the renal artery, but this was unsuccessful.Therefore, an attempt to remove rlt311417j was made but due to interference with the dsf1833 it was unsuccessful, and the rlt311417j and the dsf1833 were removed together.At that time, the thread of the perclose device was unintendedly removed together as well.(therefore, at the end of the procedure, the puncture site was surgically closed instead of using the pre-close technique.) subsequently, the advancement to the renal artery using the same dsf1833 was attempted and this time it succeeded, and the same rlt311417j was implanted without any reported issues.Then plc141200j was deployed over the left common iliac artery, but the left common iliac artery was highly calcified, and intraoperative angiography showed a distal type i endoleak.Since the endoleak remained even after balloon touch-up, the left internal iliac artery was embolized and an additional stent graft (pll161007) was implanted over the external iliac artery.As mentioned before, the procedure was completed with surgically closing the puncture site.

Manufacturer Narrative

According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential adverse events that may occur and/or require intervention include, but are not limited to, endoleak.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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15958737
• MDR Text Key: 305250031
• Report Number: 3013164176-2022-01567
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2022

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 Operator: Health Professional
• Device Catalogue Number: PLC141200J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2022
• Initial Date FDA Received: 12/12/2022
• Date Device Manufactured: 08/17/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male