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

Model Number	RLT311415
Medical Device Problem Codes	Entrapment of Device (1212); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lots met all pre-release specifications.The device will be sent for analysis.Further information will be provided.Additional information was requested but was not available.
Event or Problem Description
On (b)(6) 2021, the patient was implanted with a gore® excluder® aaa endoprosthesis featuring c3® delivery system to treat an abdominal aortic aneurysm.Reportedly, the device was completely deployed.When attempting to remove the delivery catheter, it was gripping the wire and would not release from the wire, pulling the wire along with the delivery catheter.Wire access was lost at the level of the common femoral artery.The catheter with the wire adhered to it were removed from the sheath.The wire was then was then pulled off the wire with difficulty outside of the patient.This was accomplished by clamping the wire at the hub of the sheath and pulling on the delivery catheter.According to the information provided, it is unknown what caused the delivery catheter to become stuck on the wire during withdrawal.The catheter did not appear damaged.It was reported that the aortic neck was highly angulated.The physician also mentioned that the catheter handle was leaking more than usual.However, the leakage did not require a transfusion or lead to a hurried deployment.No unplanned procedure was performed.The patient tolerated the procedure.The delivery catheter will be provided for analysis.
Additional Manufacturer Narrative
Additional information: h6.Code 213: a review of the manufacturing records for the device verified the lots met all pre-release specifications.H6.Code 10: the device remains implanted and is not available for analysis.The delivery catheter was provided for analysis and the catheter evaluation showed the following: engineering attempted to insert the guidewire provided per the gore® excluder® aaa endoprosthesis featuring c3® delivery system instructions for use (ifu) with no resistance observed.The guidewire was able to be removed from the device when pulling the wire from the leading end of the device.Engineering removed the handles covers and observed a large amount of dried blood on the spine.The glue ports were probed and appeared to be full and cured.Engineering injected green dyed water into the septum and observed water leaking from the septum at what appears to be the constraining loop pre-formed hole.Based on the findings from this evaluation, the physician¿s observation that ¿when attempting to remove the delivery catheter, it was gripping the wire and would not release from the wire, pulling the wire along with the delivery catheter¿ was not confirmed.Based on the findings from this evaluation, the physician¿s observation that ¿the catheter handle was leaking more than usual¿ was confirmed.The likely cause for the resistance felt on the guidewire could not be determined with the available information.The likely cause for the observed leakage from the septum could not be determined with the available information, but when pressurized water was injected it was noted coming from the pre-formed holes.H6.Code 4247: this code was used to cover that based on the evaluation the reported problem was not confirmed.According to the information provided, it is unknown what caused the delivery catheter to become stuck on the wire during withdrawal.The catheter did not appear damaged.It was reported that the aortic neck was highly angulated.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.Key anatomic elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation.

• Brand Name: GORE EXCLUDER 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
• MDR Report Key: 11418424
• Report Number: 3007284313-2021-01275
• Device Sequence Number: 4076674
• Product Code: MIH
• UDI-Device Identifier: 00733132619085
• UDI-Public: 00733132619085
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P020004
• 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
• Report Date (Section B): 05/20/2021

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: 07/10/2021
• Device Model Number: RLT311415
• Device Catalogue Number: RLT311415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Initial Date Received by Manufacturer: 02/13/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR