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

Catalog Number	PXC271000
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	12/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 aneurysm enlargement.As it is unknown what device the growth was attributed to, additional device implanted: pxc141400/(b)(4) has been listed.
Event or Problem Description
On (b)(6) 2012, the patient underwent treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.On an unknown date, imaging identified an unknown amount of aneurysmal growth without sign of an endoleak.The cause of growth is reportedly unknown.On (b)(6) 2018, the patient was implanted extending from contralateral leg component (lot number unknown) with a gore® iliac branch endoprosthesis and a gore® viabahn® vbx balloon expandable endoprosthesis to preserve the right internal iliac from continued disease progression of the original aneurysm.The patient tolerated the procedure.
Additional Manufacturer Narrative
H6: code 213 ¿ the review of the manufacturing paperwork verified that these lots met all pre-release specifications.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8242011
• Report Number: 2017233-2019-00025
• Device Sequence Number: 1593150
• Product Code: MIH
• UDI-Device Identifier: 00733132618224
• UDI-Public: 00733132618224
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2019

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: 01/31/2015
• Device Catalogue Number: PXC271000
• Device Lot Number: 10005475
• 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: 01/11/2019
• Supplement Report FDA Received Date: 01/30/2019
• 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: 72 YR
• Patient Weight: 110