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

Catalog Number PLC161400

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Event Date 09/19/2022

Event Type  Injury  

Event Description

On (b)(6) 2014, this patient underwent endovascular repair of an abdominal aortic aneurysm using gore excluder aaa endoprostheses.The patient tolerated the procedure.Pre-treatment cta showed that the maximum diameter of aortic aneurysm/lesion was 60.8mm.The patient had the multiple reinterventions from progressing type i and type ii endoleaks which have been already investigated and reported to fda.Reportedly, endoleaks were fixed and the patient tolerated the procedure.On september 19, 2022, a type iii endoleak-component disconnection was discovered.The aortic aneurysm was 114mm.According to the site, the aneurysm enlargement was due to the type iii endoleak.The multiple previous reinterventions from progressing endoleaks caused a type iii endoleak.On (b)(6), 2022, the patient underwent endovascular procedure to treat a type iii endoleak using a plc181000/ 22553344 device.According to the site, the event was related to the device or procedure.The endoleak was fixed.The patient tolerated the procedure.Follow up examination on august 25, 2014 showed the aneurysm measured 55 mm.From december 13, 2022 to february 16, 2023 the follow up scans showed that the maximum diameter of the aortic aneurysm/lesion increased from 125mm to 140mm.

Manufacturer Narrative

H.6.Code c21: a review of the manufacturing records for the devices are going to be conducted.The investigation is in process.The devices remain implanted and are not available for analysis.Also was implanted: (b)(6), udi# (b)(4).Code a24 was used to explain: according to the site, the multiple previous reinterventions from progressing endoleaks caused a type iii endoleak.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

H.6.Code c19: a review of the manufacturing records for the devices verified that the lots met all pre-release specifications.The devices remain implanted and are not available for analysis.Also was implanted: rlt311413/ 12536922 udi# (b)(4).Code a27 was used to cover that according to the site, the event was related to the device or procedure.The aneurysm enlargement was due to the type iii endoleak.The multiple previous reinterventions from progressing endoleaks caused a type iii endoleak.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention or additional intraoperative procedure time include but are not limited to endoleak and aneurysm enlargement.

• 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18288481
• MDR Text Key: 329994902
• Report Number: 3007284313-2023-02928
• Device Sequence Number: 1
• Product Code: MIH
• 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: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: PLC161400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2014
• 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): Other; Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Race: White