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

Catalog Number PLC271000J

Device Problem Patient-Device Incompatibility (2682)

Event Date 11/27/2023

Event Type  Injury  

Manufacturer Narrative

H.6.Investigation findings code b20: the device remains implanted and is not available for analysis.H.6.Investigation findings code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.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) 2020, a patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.Two contralateral leg components were implanted into the right common iliac artery.Details of the position of the two contralateral leg components was unknown.No follow up was performed.On an unknown date in (b)(6) 2023, a computed tomography angiography revealed a proximal type i endoleak, a type ii endoleak, an aneurismal change of the right internal iliac artery, and dilation of the right common iliac artery.On (b)(6) 2023, a reintervention was performed to embolize an inferior mesenteric artery, the origin of the type ii endoleak.On (b)(6) 2023, a reintervention was performed for the proximal type i endoleak and the right leg.The right internal iliac artery was embolized.A 18 fr gore® dryseal flex introducer sheath was unable to be advanced because the external iliac artery did not straighten.A contralateral leg component was advanced beyond the sheath tip.Then the sheath was advanced with extra force.The contralateral leg component was implanted.Then second contralateral leg component was implanted.To extend to the right external iliac artery.An aortic extender was implanted to extend proximally.No endoleak was confirmed.The patient tolerated the procedure.The physician stated that the postoperative course was unknown because there was no follow-up for 3 years after the initial treatment.

Manufacturer Narrative

As it is not known which device this event is attributable to, an additional gore® excluder® device is captured on this report: sn:(b)(6).Udi:(b)(6).Catalog: plc271200j.

• 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: bryce wargin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18417932
• MDR Text Key: 331581614
• Report Number: 3013164176-2023-01949
• 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: 12/29/2023

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 Expiration Date: 10/21/2022
• Device Catalogue Number: PLC271000J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 12/04/2023
• Supplement Dates FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/22/2019
• 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: 74 YR
• Patient Sex: Male