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

Catalog Number RLT231416J

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Sepsis (2067)

Event Date 07/24/2021

Event Type  Injury  

Event Description

The following publishment was reviewed by gore: title: outcome of treatment using excluder iliac branch endoprosthesis (ibe) in our site source: the journal of japanese college of angiology 2023: 63(suppl.) p.S197 8 evar cases (age 83 ± 4.5 years, 5 cases of male) using gore® excluder® iliac branch endoprostheses (ibe) for common iliac artery aneurysm that were performed from (b)(6) 2019 to (b)(6) 2022 at our hospital were evaluated.6 of these cases were with abdominal aortic aneurysm.4 of these cases were with internal iliac artery aneurysm.Technical success was achieved in all cases, and contralateral internal iliac artery embolization was required in 6 cases.The average postoperative observation period was 801 ± 414 days, and although one patient had open conversion due to infection and one patient had graft occlusion in internal iliac artery, there was no aneurysm enlargement (5 mm or more), and no aneurysm-related death or rupture.Outcome using ibe were good.Although there are anatomical limitations, the use of ibe is likely to continue to increase.Additional information was provided for the infection and open conversion case as in below.On (b)(6) 2021, the patient underwent endovascular treatment of an abdominal aortic aneurysm and bilateral iliac artery aneurysms using gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses.When inserting the internal iliac component into a 12 fr gore® dryseal flex introducer sheath, the catheter was difficult to be inserted.However, the catheter was able to be inserted once a pull-through was released.The patient was tolerated the procedure.On unknown date, infection was observed.On (b)(6) 2021, the open conversion was performed.The patient was taking immunosuppressant (anti-rheumatic medicine), and it was suspected that this may have been a risk.

Manufacturer Narrative

H.6:investigation findings code c19: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.H.6.: investigation conclusions: code d12 and d1001: according to the gore® excluder® aaa endoprosthesis instructions for use, potential adverse events that may occur and or require intervention, include, but are not limited to, infection and open surgical conversion.As gore was unable to determine which device/device component is involved in this reportable adverse event, the following additional devices will be identified in this report: ¿ device name : gore® excluder® aaa endoprosthesis lot # 22950815 ¿ catalog # plc271200j ¿ udi # (b)(4) ¿ device name : gore® excluder® aaa endoprosthesis ¿ lot # 22918972 ¿ catalog # pll161007j ¿ udi # (b)(4).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.

Manufacturer Narrative

Attachments: literature article attached.

• 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: kathryn irwin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18822487
• MDR Text Key: 336739164
• Report Number: 3007284313-2024-03080
• 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,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

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: 10/12/2023
• Device Catalogue Number: RLT231416J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 03/11/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2020
• 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): Required Intervention
• Patient Sex: Male