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

Catalog Number	PXT261416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.According to 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 and aneurysm enlargement.Additionally it states: users are made aware of the risks associated with type ii endoleaks in the ifu and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.
Event or Problem Description
The following information was reported to gore: on (b)(\6) 2014 a patient underwent treatment of an abdominal aortic aneurysm measuring 80mm with gore® excluder® aaa endoprostheses.On (b)(6) 2018 a cta revealed the aneurysm measured 85mm.On (b)(6) 2018 a type ii endoleak originating from lumbar branches was reported.The aneurysm measured 102mm by cta.On (b)(6) 2019 a reintervention took place whereby the right internal iliac artery was embolized.
Additional Manufacturer Narrative
Pma/510k updated.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2014 a patient underwent treatment of an abdominal aortic aneurysm measuring 80mm with gore® excluder® aaa endoprostheses.On (b)(6) 2018 a cta revealed the aneurysm measured 85mm on (b)(6) 2018 a type ii endoleak originating from lumbar branches originating from the right internal iliac artery was reported.The aneurysm measured 102mm by cta.On (b)(6) 2019 a reintervention took place.Initially micro-navigation was attempted to access the aneurysmal sac, but this was not successful.Therefore the right internal iliac artery was embolized.
Additional Manufacturer Narrative
B.3.Updated.

• 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: 8512499
• Report Number: 2953161-2019-00033
• Device Sequence Number: 1962714
• Product Code: MIH
• UDI-Device Identifier: 00733132610235
• UDI-Public: 00733132610235
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/19/2019

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: 02/29/2016
• Device Catalogue Number: PXT261416
• Device Lot Number: 11316596
• 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: 04/13/2019
• Supplement Report FDA Received Date: 05/26/2019; 06/22/2019; 08/19/2019
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 71