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

Model Number PXC201200

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2022

Event Type  Injury  

Manufacturer Narrative

Please note: this report was submitted to capture the preventative distal extension of gore® excluder® contralateral leg component (pxc201200/9704916).Type ia endoleak and proximal/distal extension of the gore® excluder® trunk-ipsilateral leg component have been captured in separate in medwatch report # 2017233-2022-03173.(b)(4).It should be noted the gore® excluder® aaa endoprosthesis instructions for use (ifu) state ¿adverse events that may occur and / or require intervention include, but are not limited to, 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.

Event Description

On (b)(6) 2012, the patient underwent endovascular treatment of an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis.On (b)(6) 2022, gradual enlargement of the aneurysm was observed.Abdominal ultrasonography reportedly revealed a proximal type i endoleak.It was suggested that type i appeared because the seal zone became shorter as the diameter of the aneurysm enlarged.On (b)(6) 2022, the patient underwent reintervention whereby additional stent grafts were implanted to extend the device system proximally, and to extend the bilateral limbs distally to prevent future type ib endoleak.The patient tolerated the procedure.

Manufacturer Narrative

H6: code c19 ¿ a review of the manufacturing records for the device verified that the lot met all pre-release specifications.It should be noted the gore® excluder® aaa endoprosthesis instructions for use (ifu) state ¿adverse events that may occur and / or require intervention include, but are not limited to, endoleak, and aneurysm enlargement.¿.

Manufacturer Narrative

H6: updated conclusion code from d12 known inherent risk of device to d14 no problem detected.Discard instruction for use statement "it should be noted the gore® excluder® aaa endoprosthesis instructions for use (ifu) state ¿adverse events that may occur and / or require intervention 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 WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: damon jackson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15131274
• MDR Text Key: 296886366
• Report Number: 2017233-2022-03174
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132610044
• UDI-Public: 00733132610044
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: PXC201200
• Device Catalogue Number: PXC201200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Male