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

Catalog Number CXT281412E

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2021, the patient underwent an endovascular treatment for an abdominal aortic aneurysm that was treated with a gore® excluder® conformable aaa endoprosthesis (cxt281412e device).Reportedly, on (b)(6) 2022, follow up computed tomography imaging showed a foreign body inside the patient.They suspected it to be the leading olive of the delivery catheter of the cxt281412e device.They reported, that the patient is asymptomatic.It was reported that the hospital¿s vascular surgery team is evaluating what to do.The team will discuss the further procedure with the patient by (b)(6) 2022.

Manufacturer Narrative

H6: codes 4112 and 4117 and 4115 and 3252: an evaluation was performed based on the event description as reported to gore and images provided from the follow up appointment provided by the physician.The physician¿s observation that the leading tip remained in the patient is consistent with the images provided.The reason for the detached leading tip cannot be determined with the available information.

Manufacturer Narrative

H6-code 4315: conclusion the delivery system was discarded at the facility.Therefore a delivery system evaluation could not be performed.The broken tip of the delivery catheter remains inside the patient.Therefore a the broken tip of the delivery catheter could not be evaluated.A review of the manufacturing records indicated the lot met all pre-release specifications.The physician provided images of the case for evaluation.The evaluation summary states that some of the images demonstrate an olive tip lodged within the distal left ipsilateral limb extension and into the left hypogastric artery.No potential new or different reasonably foreseeable risk related to the device or its use is identified.Based on the event description and the subsequent investigation, no further information was provided to gore, therefore we are unable to determine the cause of this incident and assign a root cause.

• 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13502072
• MDR Text Key: 290568764
• Report Number: 3007284313-2022-01767
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P200030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/06/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: CXT281412E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2022
• Initial Date FDA Received: 02/09/2022
• Supplement Dates Manufacturer Received: 06/22/2022; 08/05/2022
• Supplement Dates FDA Received: 07/22/2022; 08/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• 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): Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 69 KG