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	Use of Device Problem (1670)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The field sales associate (fsa) reported the following: on (b)(6) 2022, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® conformable aaa endoprostheses.It was reported that the device was prepared per ifu, however, it was difficult to remove the packaging mandrel.While attempting to advance the delivery catheter through the sheath valve, a metal piece (extending from eptfe material) punctured the sheath valve (sheath lot/serial number is unknown, hospital stock).The unknown metal (fsa stated "it is unknown what/where the wire was coming from, lock pin or apex or anchor").A hemostat was used to stop blood loss (amount of blood loss is unknown).A blood transfusion was not required.The physician used a different device and a new sheath.The patient tolerated the procedure.
Additional Manufacturer Narrative
Addition the device evaluation performed by gore engineering showed the cxt261212 excluder® conformable aaa endoprosthesis lot/serial (b)(6) was not returned for analysis, nor were any images provided for an engineering evaluation.Because no device or device images were available by which to perform an engineering evaluation, no manufacturing deficiencies could be identified and the observations in the event description could not be confirmed.

• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14353609
• Report Number: 3007284313-2022-01902
• Device Sequence Number: 4866286
• Product Code: MIH
• UDI-Device Identifier: 00733132651023
• UDI-Public: 00733132651023
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2022

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: 06/05/2024
• Device Model Number: CXT261212
• Device Catalogue Number: CXT261212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 07/13/2022
• Date Device Manufactured: 06/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female