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

Model Number CXT231212

Device Problem Partial Blockage (1065)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 12/23/2022

Event Type  Injury  

Event Description

The following was reported to gore: patient had an occluded left limb.This was occluded from the top of the bifurcation to the left hypogastric artery.There was a narrowing in the vbx device which was implanted in the left common iliac artery (cia).The initial implant on dec.16 was with a pll161007 above the lcia and had an extension of a 8l x79.Thrombectomy catheter was used and opened vessel and than we used kissing 8l stents just above flow divider to restore flow.Patient doing well.

Manufacturer Narrative

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 - the review of the manufacturing paperwork verified that this lot met all pre-release specifications.H6: code d12 ¿ according to thegore® excluder® conformable aaa.Endoprosthesisinstructions for use, adverse events with may occur and/or require intervention including, but not limited to, occlusion of device or native vessel.

• Brand Name: GORE® EXCLUDER® CONFORMABLE 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 SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16184324
• MDR Text Key: 307499743
• Report Number: 2953161-2023-01165
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132651009
• UDI-Public: 00733132651009
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

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 Model Number: CXT231212
• Device Catalogue Number: CXT231212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2022
• Initial Date FDA Received: 01/17/2023
• Supplement Dates Manufacturer Received: 12/23/2022
• Supplement Dates FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female