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

Catalog Number	RMT281416
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/10/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.
Event or Problem Description
The following information was received by gore: on (b)(6) 2014, this patient underwent endovascular treatment for an abdominal aortic aneurysm measuring 65 mm in diameter and was therefore implanted with gore® excluder® aaa endoprostheses.On (b)(6) 2014, follow-up ultrasound examination found the aneurysm to measure 60 mm and 62 mm on (b)(6) 2014.Follow-up computed tomography angiography imaging on (b)(6) 2017, and on (b)(6) 2019, showed the aneurysm diameter to have further increased from 68 to 80 mm.There was no reason reported for the aneurysm increase.
Additional Manufacturer Narrative
B5.Describe event or problem: added additional information.H6.Device code 1: corrected code.H6: code 22 - according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), complications associated with the use of the gore® excluder® aaa endoprosthesis may include but are not limited to: endoleak and aneurysm enlargement.
Event or Problem Description
On (b)(6), 2019, follow-up imaging identified a type ii endoleak originating from a lumbar artery at the level of vertebrae l3/l4 and on (b)(6), 2019, cta follow-up imaging confirmed an aneurysm diameter of 80 mm.On (b)(6), 2019, the endoleak was embolized.Follow-up cta imaging on (b)(6), 2019, revealed an aneurysm diameter of 83 mm.
Additional Manufacturer Narrative
B5: updated field content.H6 device code 1: corrected code.H6: code 22 - according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), complications associated with the use of the gore® excluder® aaa endoprosthesis may include but are not limited to: endoleak and aneurysm enlargement.
Event or Problem Description
On (b)(6) 2019, the patient was administered to hospital for follow-up imaging to be conducted the next day.On (b)(6) 2019, a type ii endoleak originating from a lumbar artery at the level of vertebrae l3/l4 was diagnosed with the aneurysm measuring 80 mm.On (b)(6) 2019, angiography was performed and the endoleak was embolized.Follow-up cta imaging on (b)(6) 2019, found an aneurysm diameter of 83 mm.According to the physician, this increase is not considered an aneurysm enlargement as the patient was given an embolizate and there is a tolerance of measurement.The endoleak is believed to have been repaired.

• 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: 8895894
• Report Number: 2017233-2019-00650
• Device Sequence Number: 1617286
• Product Code: MIH
• UDI-Device Identifier: 00733132610723
• UDI-Public: 00733132610723
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 12/09/2019

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: 11/30/2016
• Device Catalogue Number: RMT281416
• Device Lot Number: 12117537
• 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: 08/15/2019
• Supplement Report FDA Received Date: 11/12/2019; 01/06/2020
• 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: Hospitalization
• Patient Age: 75 YR
• Patient Weight: 87