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

Model Number	CXA320005
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, this patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.During implantation of a gore® excluder® aaa conformable aortic extender endoprosthesis, the leading olive became dislodged from the delivery catheter inside the patient.The olive was successfully retrieved.There was no known resistance during advancement or withdraw of the delivery catheter.There was no harm to the patient.The procedure was completed successfully.
Additional Manufacturer Narrative
G4:p200030.H1/h2: correction.H10/11: corrected g4.
Additional Manufacturer Narrative
Additional manufacturer narrative: the device evaluation performed by engineering showed the following: ¿ the leading tip was not attached to the leading end of the returned device catheter.¿ neither the leading tip nor the location on the catheter where the tip would be bonded showed any material reflow or signs of bonding, which is consistent with a lack of bond or an insufficient bond between the leading tip and catheter.¿ no damage was identified to tip and the proximal end of the catheter.Based on the findings from the evaluation, the condition of the returned device is consistent with the physician¿s observation that the ¿leading olive separate[d] from the catheter¿.Evidence of insufficient bonding between the leading tip and catheter was observed, and the greatest severity of harm for this failure mode documented in the conformable excluder (cexc) process failure modes and effects analysis (pfmea) ((b)(4)) revision 17 is ¿critical¿.Therefore, capa request or134922, which captures this event, was generated per md145952 revision 22, but capa101692 currently exists and addresses the occurrence observed in this event.Corrected data: h6: component code, investigation findings and investigation conclusion codes added.

• 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: douglas rhodes ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12274924
• Report Number: 3007284313-2021-01532
• Device Sequence Number: 17309339
• Product Code: MIH
• UDI-Device Identifier: 00733132650965
• UDI-Public: 00733132650965
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/29/2022

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: 11/24/2023
• Device Model Number: CXA320005
• Device Catalogue Number: CXA320005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 07/07/2021; 07/07/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 11/11/2021; 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Unknown