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

Catalog Number PLC161400

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Event Date 12/24/2020

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.From (b)(6) 2014 to (b)(6) 2020 the follow up scans showed that the maximum diameter of the aortic aneurysm/lesion increased from 55mm to 107mm.Additionally, on (b)(6) 2020, a distal right limb type i endoleak was determined.It was reported that a loss of seal of the right distal iliac limb to the common iliac artery caused a distal type i endoleak.The patient had a severe tortuosity of the right iliac system.Reportedly, a distal type i endoleak caused an aneurysm enlargement.On (b)(6) 2021, the patient underwent endovascular procedure using gore excluder aaa endoprostheses (plc201400/ 2258291 and plc181400/ 22477819).The patient tolerated the procedure.

Manufacturer Narrative

H.6.Code c21: a review of the manufacturing records for the device is going to be conducted.The investigation is in process.The device remains implanted and is not available for analysis.Code a27 was used to cover the loss of seal of the right distal iliac limb to the common iliac artery.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

H6: code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remains implanted and is not available for analysis.Code a27 was used to cover the loss of seal of the right distal iliac limb to the common iliac artery.The patient had a severe tortuosity of the right iliac system.It was reported that a loss of seal of the right distal iliac limb to the common iliac artery caused a distal type i endoleak, and a distal type i endoleak caused an aneurysm enlargement.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.Per ifu, additional considerations for patient selection include but are not limited to: patient¿s anatomical suitability for endovascular repair.Ilio-femoral access vessel size and morphology (minimal thrombus, calcium and/or tortuosity) should be compatible with vascular access techniques.Additionally, the ifu states that an inadequate sealing may lead to endoleak.

• 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: 18441447
• MDR Text Key: 331863931
• Report Number: 3007284313-2024-02988
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618729
• UDI-Public: 00733132618729
• 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: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• 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: 01/08/2024
• 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