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

Catalog Number	PLA360400
Medical Device Problem Codes	Disconnection (1171); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As it is unknown which excluder® aortic extender components were involved in the reported type ii endoleak, additional endoprosthesis components pla360400/15594977 and pla360400/13306926 have been included in this report.A review of the manufacturing records for the devices verified that the lots met all pre-release specifications.Per the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to endoleak.Per ifu, considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.
Event or Problem Description
On (b)(6) 2016, the patient was implanted with three gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.On (b)(6) 2017, the patient was implanted with two excluder® aortic extender components.On an unknown date, follow-up examination reportedly revealed a type iii endoleak (component disconnection) between two of the aortic extender components.The physician attributed the endoleak to tortuous aortic anatomy.On (b)(6) 2018, the patient underwent a re-intervention procedure whereby two 40mm x 10cm gore® tag® thoracic endoprostheses were implanted to treat the type iii endoleak.The endoleak was resolved and the patient tolerated the procedure.
Additional Manufacturer Narrative
Correction: as it is unknown which excluder® aortic extender components were involved in the reported type iii endoleak, additional endoprosthesis components pla360400/15594977 and pla360400/13306926 have been included in this report.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8115598
• Report Number: 2953161-2018-00099
• Device Sequence Number: 1516514
• Product Code: MIH
• UDI-Device Identifier: 00733132618439
• UDI-Public: 00733132618439
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2018

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: 02/14/2019
• Device Catalogue Number: PLA360400
• Device Lot Number: 14775100
• 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
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 12/20/2018
• 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; Required Intervention
• Patient Age: 77 YR