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

Catalog Number	RMT231216
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
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c3® delivery system.The device was advanced over a lunderquist wire through an 18fr gore® dryseal sheath.The sheath was retracted for deployment.The first stage of deployment was attempted but it did not deploy.The back-up deployment hatch was opened and attempts to deploy the system using the back-up lines were made.However the first stage of deployment could not be accomplished.The system was removed from the patient and a decision was made to re-schedule the procedure.There was no injury to the patient.
Additional Manufacturer Narrative
Date received by mfr updated.
Additional Manufacturer Narrative
Results code 2: 213: the engineering evaluation stated the following: the device evaluation showed the following: the 1st deployment knob was not returned.The backup access hatch has been removed and the constraining loop and lock pin are pulled out through the opening.The hatch was not returned.The 1st deployment line appears to have broken and is visible at the leading end of the un-deployed device.The two slip knots which normally unlace after the line loop in the deployment sequence, appear to be intact.The inspection revealed that one side of the line loop is still laced and tucked as it should be, under the sleeve 3rd double stitch.The single and double stitch sides of the sleeve were inspected and no abnormalities were noticed.Scanning electron microscopy imaging was performed.The observed smooth edge of the fep/eptfe overwrap appears to be consistent with that produced with a sharp cutting edge.The failure mode of the inner core is inconclusive.Based on the findings from this evaluation, the physician¿s observation that the endoprosthesis did not deploy when the initial deployment line was pulled was confirmed and is consistent with the observed broken deployment line.The break appears to be consistent with all or part of the fiber cross section being severed with a sharp cutting edge.The likely cause for the broken deployment line could not be determined with the currently available information.

• 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: 8408116
• Report Number: 3007284313-2019-00064
• Device Sequence Number: 10840985
• Product Code: MIH
• UDI-Device Identifier: 00733132610525
• UDI-Public: 00733132610525
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2019

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: 08/29/2019
• Device Catalogue Number: RMT231216
• Device Lot Number: 15425567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 05/23/2019; 06/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 75