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

Catalog Number CXT321414

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

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

Event Date 04/09/2024

Event Type  Injury  

Event Description

On (b)(6) 2024, the patient was treated for a zone 9 abdominal aortic aneurysm.After deploying a gore® excluder® conformable aaa endoprosthesis cxt321414, an angiogram was performed to confirm the graft was in the desired location.It was decided that it was a bit higher than planned, so the device was reconstrained and moved down about half a centimeter and redeployed.Another angiogram was taken, and it was decided to move it down an additional 3mm.The device was reconstrained, but the left side appeared to pull down, as if the reconstraining loop was not working properly.The physician reconstrained the device again, and moved the device up and then down and deployed again, but the left side once again seemed to pull down.The physician decided to implant the contra leg plc161000 and ballooned the devices.The cxt still had the left side pulled down, but appeared apposed to the aortic wall, and no endoleak was noted.The patient tolerated the procedure.

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.: type of investigation: code b20: device remains implanted and therefore not available for direct analysis.H.6.: type of investigation: code b22: see imaging evaluation.H.6.: investigation conclusions: code 14: imaging evaluation showed the following: the image(s) received cannot be used to perform an imaging evaluation due to the insufficient data and/or poor quality of the image(s) provided h.6.: investigation conclusions: code d12: according to the gore® excluder® conformable aaa endoprosthesis instructions for use (ifu), potential adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: endoprosthesis or delivery system: improper component placement; incomplete component deployment; unintentional / premature component deployment; leading end catheter component retention; component migration.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.: investigation conclusions: code d15, added.

• 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 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: 19196281
• MDR Text Key: 341483040
• Report Number: 3007284313-2024-03199
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132651061
• UDI-Public: 00733132651061
• 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: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CXT321414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2024
• 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 Age: 67 YR
• Patient Sex: Male