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

Catalog Number	RLT351416
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, this patient underwent endovascular repair to treat an abdominal aortic dissection with an internal iliac artery aneurysm.The patient was reported to have poor anatomy and poor aortic tissue prior to the procedure.The internal iliac artery aneurysm was coil embolized.Then a gore® excluder® aaa endoprosthesis featuring c3 deployment system was advanced into the abdominal aorta.When the device was deployed, the contralateral leg gate opened into a dissected plane.Therefore, the physician was unable to cannulate the gate.The decision was made to convert to an open repair.The gore® excluder® device was explanted and discarded at the facility.There were no allegations against the device.The physician stated that the patient's anatomy was poor, and this was the cause of the conversion to open repair.

• 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: 8811736
• Report Number: 3007284313-2019-00209
• Device Sequence Number: 2587351
• Product Code: MIH
• UDI-Device Identifier: 00733132618484
• UDI-Public: 00733132618484
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/24/2022
• Device Catalogue Number: RLT351416
• Device Lot Number: 20390956
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2019
• 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: Required Intervention
• Patient Age: 54 YR