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

Catalog Number PLC201000

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Extravasation (1842); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Rupture (2208)

Event Date 12/06/2023

Event Type  Injury  

Manufacturer Narrative

H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.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 bleeding complications, hypotension and vascular spasm or vascular trauma (rupture).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 endovascular procedure in zone 9 infrarenal to treat an abdominal aortic aneurysm (aaa) with an enlarged right common iliac artery utilizing one gore® excluder® conformable aaa endoprosthesis (b)(4), three gore® excluder® aaa endoprosthesis (plc161200, plc201000 and plc161400), two gore® molding & occlusion balloon catheter (mob37) and two gore® dryseal flex introducer sheath (dsf1233 and dsf1633).Reportedly, during the case, everything went as planned with all devices deployed successfully with no deployment or positioning issues as all devices landed at the intended location.Near the end of the procedure, ballooning was being done in the common iliac arteries when the anesthesia rep notified that they lost pressure, then an angiography was done and it showed that the right common iliac artery was bleeding out (extravasation).The physician then bridged from the proximal end of the right common iliac component into the external iliac artery with another piece of the excluder graft (plc161400) and sealed the extravasation.No blood loss visible on outside of the patient and blood loss volume is unknown inside the patient.Physician is not aware of the reason for the bleeding as there were no anatomical issues but the bleeding occurred during the ballooning of the excluder graft (plc201000) and the balloons functioned properly and were used to stop the blood flow after bleeding was noticed coming into the right common iliac component in order implant the additional excluder graft (plc161400) and no extravasation was noted after.They stabilized the bleeding and patient is doing okay.Anesthesia was not doing anything additional at that point of time with vascular support and procedure was completed successfully.

Manufacturer Narrative

Corrected h6: investigation conclusion: d15 (cause not established).

• 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: 18376966
• MDR Text Key: 331182500
• Report Number: 3013164176-2023-01938
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618590
• UDI-Public: 00733132618590
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 01/16/2024

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: PLC201000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 01/15/2024
• Supplement Dates FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2023
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 60 KG