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

Catalog Number PLA280300

Device Problems Partial Blockage (1065); Obstruction of Flow (2423); Unintended Movement (3026)

Patient Problems High Blood Pressure/ Hypertension (1908); Obstruction/Occlusion (2422)

Event Date 10/23/2023

Event Type  Death  

Manufacturer Narrative

H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.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 occlusion of device or native vessel, cardiac complications (hypertension), surgical cut down (bypass or conversion) and death.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) 2010, the patient underwent an endovascular abdominal aortic aneurysm (aaa) repair utilizing a gore® excluder® aaa endoprosthesis (pxc141400 and pxt261418).Patient has had annual abdominal u/s surveillance which have shown no definitive leaks, however, the aaa has shown a gradual increase in size over the last 10 years.This year, the surveillance revealed a 5.4cm aaa which is a 4mm increase in size from last year's scan.A cta was ordered (date unknown) which revealed the aaa was closer to 5.7cm.Again, there was no definitive leaks seen but in review with a field sales associates (fsa) there may be a wisp of contrast coming from the top of the graft on the right side and the right limb is barely seated in the iliac artery.Patient denies abdominal pain.On october 20, 2023, fsa was notified that physician plans to intervene as there may be a possible type 1a endoleak that they suspected due to expanding aneurysm but unknown if its coming from the trunk ipsilateral or contralateral leg.On (b)(6) 2023, the patient was brought in for a reintervention procedure by extending proximally from the bifurcated stent grafts (trunk ipsilateral leg and contralateral leg) as there was room to extend till both the renal arteries and also extend to the iliac arteries.Reportedly, the physician deployed the gore® excluder®aaa endoprosthesis (aortic extender) proximally, which partially covered the right renal artery and left renal artery was completely open.Both renals were big so it was not a concern at the time with efficient blood flow.Physician then attempts to initially balloon the overlap between the aortic extender and bifurcated graft and was satisfied with the initial deployment.However, at some point, it was noticed that the aortic extender moved and covered both the renal arteries.Its possible the extender moved when physician ballooned it.Physician then tried to bring down the device with an aortic balloon but could not get it down then a wire was put in above the bifurcated grafts and physician is tugging really hard which ended up pulling the bifurcated grafts from the aortic extender by 7cm to the bottom of the aorta.Physician then planned to realign the whole graft but at that time patient's blood pressure started going up sharply and balloon was put back in to pull the extender down but that did not resolve the issue.Due to the bifurcated grafts being pulled down, it occluded the aorta which led to increase in blood pressure, after which, the physician switched to open repair and explanted all the grafts and closed the patient.Blood pressure continued to increase and physician reopened the patient at which point patient passed away due to multiple trauma due to surgery.2000-e:-migration events - other/unknown used to capture the device movement of the bifurcated grafts by 7cm.2100-e:-leakage events endoleak - other/unknown used to capture growing aneurysm due to endoleak.2200-e:-vessel coverage - other/unknown used to capture the occlusion of the aorta.

• 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: 18154925
• MDR Text Key: 328350214
• Report Number: 3013164176-2023-01899
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618781
• UDI-Public: 00733132618781
• 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
• 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 Expiration Date: 12/27/2023
• Device Catalogue Number: PLA280300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2023
• Date Device Manufactured: 12/28/2020
• 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): Death; Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male