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

Model Number CXA320005

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2021

Event Type  malfunction  

Event 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.

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.

Manufacturer Narrative

G4:p200030.H1/h2: correction.H10/11: corrected g4.

• 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: douglas rhodes ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12274924
• MDR Text Key: 264984425
• Report Number: 3007284313-2021-01532
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132650965
• UDI-Public: 00733132650965
• 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,Followup,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR