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

Catalog Number	PXC181200
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/16/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore: on (b)(6) 2012, this patient underwent endovascular treatment for an abdominal aortic aneurysm with a diameter measuring 52 mm and was treated with gore® excluder® aaa endoprostheses.On (b)(6) 2013, computed tomography angiography imaging (cta) identified the aneurysm measuring 46 mm.On (b)(6) 2014, and on (b)(6) 2016, ct imaging identified the aneurysm measuring 48 mm and 50 mm, respectively.During follow-up cta imaging on (b)(6) 2018, it was found that the gore® excluder® contralateral leg component pxc181200 / (b)(4) implanted on the right patient side had short shortened due to disease progression.A type 1b endoleak was however not reported.Additionally, an aneurysm diameter of 51 mm was confirmed.On (b)(6) 2018, an additional stent was implanted into the right common iliac artery to extend the pxc181200 component to again provide adequate seal.
Additional Manufacturer Narrative
Code 213 - the review of the manufacturing records verified that the lot involved in this event 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: 8088699
• Report Number: 2017233-2018-00707
• Device Sequence Number: 1459706
• Product Code: MIH
• UDI-Device Identifier: 00733132610013
• UDI-Public: 00733132610013
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2018

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: 07/31/2013
• Device Catalogue Number: PXC181200
• Device Lot Number: 8203287
• 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: 11/20/2018
• Supplement Report FDA Received Date: 12/07/2018
• 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: 85