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

Model Number	CXT261212
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to gore: on (b)(6)2021, the patient presented with an unknown etiology at an unknown anatomical location and underwent treatment utilizing a gore® excluder® conformable aaa endoprosthesis (cxt).The physician delivered the cxt device through an 18f dry seal sheath over a meier wire.The cxt device was fully deployed.Upon removal of the delivery system, the olive tip broke off, the physician successfully snared the olive tip and it was removed without further issue.The procedure was completed and the patient tolerated the procedure.
Additional Manufacturer Narrative
Based on the findings from the evaluation, the condition of the returned device is consistent with the physician¿s observation that ¿upon removal of the delivery system, the olive tip broke off¿.Evidence of an insufficient bond between the leading tip and catheter was observed.
Additional Manufacturer Narrative
Added h6 component code and conclusion code.
Additional Manufacturer Narrative
Added g3/g4 for pma/510(k) number and, h1/h2, h6.

• Brand Name: GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS
• Common Device Name: 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 SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: liam schultz ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12214958
• Report Number: 2017233-2021-02194
• Device Sequence Number: 17186772
• Product Code: MIH
• UDI-Device Identifier: 00733132651023
• UDI-Public: 00733132651023
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/16/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/18/2022
• Device Model Number: CXT261212
• Device Catalogue Number: CXT261212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 06/22/2021; 02/07/2022; 03/09/2022
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 01/06/2022; 02/07/2022; 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female