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

Catalog Number CXT321414

Device Problem Patient-Device Incompatibility (2682)

Event Date 03/01/2024

Event Type  Injury  

Manufacturer Narrative

H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.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

The following was reported to gore: on (b)(6) 2023, the patient under an endovascular aortic repair utilizing a gore® excluder® conformable aaa endoprosthesis (conformable trunk ipsilateral leg) and gore® excluder® aaa endoprosthesis (contralateral leg).Patient was followed up by the physician for a ct scan sometime in 2023 (date unknown) where aneurysm measured 5.6 x 6cm with a type 1a endoleak.Patient had another ct sometime in february 2024 (date unknown) where the aneurysm measured 6.6 x 6.0cm with a remaining type 1a endoleak.On (b)(6) 2024, the field sales associate was notified by the physician that the patient will undergo a reintervention to treat the type 1a endoleak and the growing aneurysm.On (b)(6) 2024, reportedly, the physician scheduled patient for a revision of the aortic endograft.Physician used a gore® excluder® conformable aaa endoprosthesis (trunk ipsilateral conformable leg), a physician modified device plus two gore® excluder® aaa endoprosthesis (contralateral legs).The type 1a endoleak on the conformable trunk ipsilateral leg was resolved.Patient tolerated procedure and is reported to be doing fine.

• 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: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19142520
• MDR Text Key: 340580391
• Report Number: 3007284313-2024-03182
• 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
• Report Date: 04/19/2024

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 Catalogue Number: CXT321414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Date Device Manufactured: 04/26/2023
• 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: 89 YR
• Patient Sex: Female