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

Model Number CXT261412

Device Problem Insufficient Information (3190)

Patient Problem Aneurysm (1708)

Event Date 12/22/2021

Event Type  Injury  

Event Description

On (b)(6) 2021 the patient underwent treatment for an abdominal aortic aneurysm and was implanted with gore ® excluder ® conformable aaa endoprosthesis (cxt261412) and with gore ® excluder ® aaa endoprostheses (plc14100, plc201200, and plc121400).The plc 121400 was extended into the ipsilateral limb on the right side of the patient.A 3cm of overlap was observed between the cxt261412 and the plc121400 at the time of the procedure.A follow up ct scan was performed on an unspecified date and it was observed that the there was no overlap between cxt261412 and the plc121400 endoprostheses.The plc121400 had migrated to the end of the ipsilateral limb on the cxt261412.A type iii endoleak was observed.On (b)(6) 2021 a reintervention was performed in which a plc 161400 was implanted to treat the type iii endoleak.The patient tolerated the procedure and the endoleak was resolved.

Manufacturer Narrative

H6 code 213 - no device problem found: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.

Manufacturer Narrative

G3/g4, pma/510k number incorrectly entered previously and changed to p200030.

• 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: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13114635
• MDR Text Key: 288184952
• Report Number: 3007284313-2021-01732
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132651030
• UDI-Public: 00733132651030
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2022

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 Expiration Date: 11/22/2023
• Device Model Number: CXT261412
• Device Catalogue Number: CXT261412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 12/22/2021; 03/16/2022
• Supplement Dates FDA Received: 01/04/2022; 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2020
• 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; Hospitalization; Other
• Patient Age: 71 YR
• Patient Sex: Male