MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	RLT281218
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.An engineering evaluation is currently in progress.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2019 a patient was undergoing treatment of an abdominal aortic aneurysm with a gore® excluder® aaa endoprosthesis featuring c3® delivery system.The device was being placed within another evar graft.The first stage of deployment was completed.Blood was noted to be leaking from the handle.The constrainment mechanism was removed to see if it would help.The contralateral gate was successfully cannulated and the ipsilateral leg was deployed.The case was completed.The patient tolerated the procedure and no transfusion was required.
Additional Manufacturer Narrative
Conclusion code 1: updated results code 2: the engineering evaluation stated the following: the device evaluation showed the following: the tuohy-borst valve appeared to be aligned with the spine and fully tightened.Engineering removed the spine covers and the spine was examined.No abnormalities were noted.The septum appeared to be intact with no obvious damage.The glue ports and guide-wire trough were inspected and appeared to be filled with glue.Green dyed water was pressurized though the septum into the manifold area to determine the location of the leakage.Water was observed leaking out of the manifold guidewire lumen trough.Based on the findings from this evaluation, the physician¿s observation that blood leaked from the handle was confirmed.The likely cause for the observed leakage was an incomplete seal caused by an insufficient amount of glue between the manifold lid and the guide wire lumen trough.Conclusion code 2: 22: according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but is not limited to bleeding.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8652324
• Report Number: 3007284313-2019-00158
• Device Sequence Number: 2075378
• Product Code: MIH
• UDI-Device Identifier: 00733132622511
• UDI-Public: 00733132622511
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2019

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: 09/20/2019
• Device Catalogue Number: RLT281218
• Device Lot Number: 15494769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1