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

Model Number	RLT261416
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Insufficient Information (4580)
Date of Event	08/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products and therapy dates: unavailable.(b)(4).
Event or Problem Description
On (b)(6) 2014, the patient underwent endovascular treatment of an abdominal aortic aneurysm (aaa) with a maximum diameter measuring 50.3mm.Four gore® excluder® aaa endoprostheses were implanted.The patient tolerated the procedure and was discharged to home on (b)(6) 2014.On (b)(6) 2017, an endoleak of indeterminate origin was observed.On the same day an intervention was performed whereby the endoleak was embolized.
Additional Manufacturer Narrative
B.4.Event description added.H.6.Investigation conclusions: code 22 - according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and/or require intervention include, but are not limited to, endoleak and aneurysm enlargement.Furthermore, the ifu informs users of the risks associated with type ii endoleaks, and users are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.H.6.Health effect - clinical code updated from 4580 to 1708.H.6.Medical device problem code updated from 3190 to 2682.H.6.Investigation conclusions updated from 4315 to 22.
Event or Problem Description
Pre-treatment maximum diameter of the abdominal aortic aneurysm was 50.3mm.Follow-up cta on (b)(6) 2015 revealed the aneurysm measured 47.0mm.Follow-up cta on (b)(6) 2017 revealed the aneurysm measured 52.0mm.On (b)(6) 2017 a type ii endoleak from the inferior mesenteric artery inflow and a right lower lumbar artery outflow was observed.On the same day an intervention was performed whereby the endoleak was embolized.The embolization procedure was successful.The patient was discharged on the same day.Follow-up cta on (b)(6) 2017 revealed that the endoleak was no longer visualized.
Additional Manufacturer Narrative
B3.Date of event: as aneurysm enlargement of 5mm was noted on (b)(6) 2017, the event date has been updated/corrected.
Additional Manufacturer Narrative
Updated manufacturing address to: woody mountain 3750 w kiltie ln flagstaff, az 86005.

• Brand Name: GORE EXCLUDER AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11616524
• Report Number: 3007284313-2021-01370
• Device Sequence Number: 2998718
• Product Code: MIH
• UDI-Device Identifier: 00733132622467
• UDI-Public: 00733132622467
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/20/2021

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: 05/31/2017
• Device Model Number: RLT261416
• Device Catalogue Number: RLT261416
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 05/03/2021; 07/07/2021; 07/07/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/10/2021; 07/07/2021; 08/20/2021
• 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 Weight: 81