MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)

Model Number	PLA360400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, the patient was implanted with a gore® excluder® aaa endoprosthesis featuring c3® delivery system.It was reported that on (b)(6) 2019, a followup imaging study was performed.A possible type ia endoleak was noted at that time.The physician will follow up with another imaging study in the future.
Additional Manufacturer Narrative
H10/11: additional manufacturer narrative/corrected data - as endoleaks without reported enlargement or reintervention are not considered caused or contributed by the gore device, this medwatch is hereby retracted.
Additional Manufacturer Narrative
H1: type of event - other.
Additional Manufacturer Narrative
H1: type of reportable event : other.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8889964
• Report Number: 3013164176-2019-00104
• Device Sequence Number: 11139116
• Product Code: MIH
• UDI-Device Identifier: 00733132618439
• UDI-Public: 00733132618439
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• 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,Followup,Followup
• Report Date (Section B): 01/28/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/29/2021
• Device Model Number: PLA360400
• Device Catalogue Number: PLA360400
• Device Lot Number: 18185781
• 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; Not provided
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 08/19/2019; 01/17/2020; 01/29/2020
• 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: 86 YR