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

Catalog Number RLT311417

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 01/09/2024

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.H3: other code and h6: code b20 - the device remains implanted in the patient.Therefore, a device evaluation could not be performed.The imaging evaluation performed by a clinical imaging specialist showed the following: four post-implant cta¿s provided for evaluation dated on (b)(6) 2024, and 2 image sets completed on (b)(6) 2024.Pet scan imaging also provided with a date on (b)(6) 2024.A medical report detail is included in the summary description.The scan on (b)(6) 2024 is a chest only scan.The end of the scan is at the level of the proximal implanted device.On (b)(6) 2024, cta shows the ipsilateral leg extends into the lci and a contralateral leg is implanted within and extending distally into the left external iliac artery.The liia is occluded.The contralateral gate is on the patient¿s right side with a contralateral limb implanted in the rci.The pet ct scan was completed on (b)(6) 2024.(see medical report in summary description.) the abd/pelvis cta on (b)(6) 2024 does not show any new finding with the devices.The cta scan of the legs shows flow in the left sfa/popliteal arteries and distally past the at take off.Sterilization records are being reviewed.Per gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: infection (e.G., aneurysm, device or access sites).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

It was reported to gore that a gore® excluder® aaa endoprosthesis (rlt311417, plc141000 on the left, and plc271000 on the right) was implanted for an endovascular aneurysm repair (evar).On (b)(6) 2024, the patient had a temperature spike and left abdominal pain and left knee pain.Ct showed fluid collection related to the lt anterior lateral lower abdominal aorta and prominent soft tissue process related to the left common and external iliac arteries.The physician could not exclude the possibilities of infected fluid collection or infected inflammatory process related to the evar.On (b)(6) 2024, the patient received iv antibiotics due to hydronephrosis and proximal hydroureter.On (b)(6) 2024, a pet ct scan showed diffuse abnormal fdg uptake surrounding the stent and the walls of the residual aaa sac suspicious for stent infection.A large fdg - avid fluid collection in the left psoas muscle surrounding the left iliac stent measuring 6 cm in axial diameter.No other foci of abdominal fdg uptake was observed.The physician suspect a probable infection of the aortic aneurysm stent associated with the large left psoas muscle abscess as described.The patient received continued iv antibiotics on (b)(6) 2024.On (b)(6) 2024, ct showed multioculated rim enhancing psoas collection adjacent to the left midsection of the stent graft, lying immediately adjacent to the right thrombozed left external iliac, aaa and the occluded proximal part of the left internal iliac artery.The mass effected the left external iliac vein with a suggestion of sub acute deep vein thrombosis.Poor opacification of the right common iliac, external and femoral arteries and right common.Patient was subsequently discarded from the hospital on (b)(6) 2024 on iv antibiotics.The physician diagnosed the patient on (b)(6) 2024 with a evar graft infection and left psoas abscess.The patient will continue iv antibiotics and review in 6 weeks.It was reported that no further intervention is planned even in case of rupture.

Manufacturer Narrative

D10: concomitant medical products: (relevant associated devices used with the device being reported on): gore® excluder® aaa endoprosthesis - contralateral leg endoprosthesis (plc141000 and plc271000).H6: added e2328 and e0514.Updated c21 to c19, updated d16 to d15.A review of the sterilization records indicated the lot met all pre-release sterilization specifications.Based on the incident description and the subsequent investigation, no further information was provided to gore, we are unable to determine the cause of this incident and assign a root cause.Per gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: occlusion of device or native vessel.

• 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: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18948199
• MDR Text Key: 338187702
• Report Number: 3007284313-2024-03124
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132619092
• UDI-Public: 00733132619092
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2024

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 Expiration Date: 03/21/2021
• Device Catalogue Number: RLT311417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2018
• 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
• Treatment: SEE H10
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 61 KG