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

Catalog Number	PLC161200
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/21/2018
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
Gore received the following information: on (b)(6) 2015, this patient underwent endovascular treatment for an abdominal aortic aneurysm measuring 59 mm in diameter and was therefore treated with gore® excluder® aaa endoprostheses.On (b)(6) 2015, follow-up computed tomography (ct) imaging identified an aneurysm diameter of 61 mm.After a continuous slight decrease to 58 mm until (b)(6) 2016, follow-up computed tomography (ct) imaging revealed an aneurysm diameter of 71 mm on (b)(6) 2018.With an onset date of (b)(6) 2018, retroperitoneal bleeding from the right common iliac artery was identified.On the same day, a re-intervention was performed and an additional stent was implanted into the right external iliac artery as an extension.Additionally, the right internal iliac artery was plugged.
Event or Problem Description
On (b)(6), 2018, and due to the observed aneurysm growth, a re-intervention was performed and an additional gore® excluder® endoprosthesis was preventively implanted as an extension into the right external iliac artery.However, later that day, the patient became hypotonic and ct imaging showed a bleeding originating from the right common iliac artery due to an injury that had occurred during the implant procedure.To remedy the situation, another stentgraft was placed into the external iliac artery as an extension and the right internal iliac artery was plugged.
Additional Manufacturer Narrative
B5.Describe event or problem: event description was updated/corrected in part.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: aneurysm enlargement.

• 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: 8524768
• Report Number: 3007284313-2019-00112
• Device Sequence Number: 2689486
• Product Code: MIH
• UDI-Device Identifier: 00733132618705
• UDI-Public: 00733132618705
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2019

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: 09/30/2017
• Device Catalogue Number: PLC161200
• Device Lot Number: 13149012
• 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: 04/17/2019
• Supplement Report FDA Received Date: 08/27/2019
• 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; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 80