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

Catalog Number	RLT281212
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.The gore® excluder® trunk-ipsilateral leg component rlt281212 remains implanted into the patient.Therefore, an engineering evaluation of the device could not be performed.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was treated with gore® excluder® aaa endoprostheses.The contragate did not open fully during first stage deployment of a gore® excluder® trunk-ipsilateral leg component rlt281212.After a time intensive process of cannulating the contragate due to the reduction in diameter, the clinician advanced a 12 french gore® dry seal flex introducer sheath, to which the contragate visibly 'popped' open.Reportedly, all procedural steps were followed according to the instructions for use and the 18fr gore® dry seal flex introducer sheath was retracted approximately 25/30mm distally from the contragate marker on first stage deployment.The reason for the initially inhibited full deployment of the contragate was reportedly unknown and there was no calcification or tortuous anatomy that was thought to have contributed to this incident.The patient tolerated the procedure.
Additional Manufacturer Narrative
A.Patient information: added 1.Patient identifier.
Additional Manufacturer Narrative
Initial reporter name and address: and phone #: corrected data.

• 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: 7831748
• Report Number: 3007284313-2018-00245
• Device Sequence Number: 13938149
• Product Code: MIH
• UDI-Device Identifier: 00733132622481
• UDI-Public: 00733132622481
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2018

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: 02/14/2021
• Device Catalogue Number: RLT281212
• Device Lot Number: 17787601
• Was Device Available for Evaluation?: No
• 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: 08/30/2018
• Supplement Report FDA Received Date: 09/03/2018; 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 78 YR