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

Catalog Number	PXA260300
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The gore® excluder® aaa endoprosthesis instructions for use (ifu) states ¿the gore excluder® aaa endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (aaa) disease.¿ additionally, per ifu, ¿the aortic and iliac extender endoprostheses are intended to be used after deployment of the gore excluder® aaa endoprosthesis.These extensions are intended to be used when additional length and / or sealing for aneurysmal exclusion is desired.¿ further, the ifu states ¿adverse events that may occur and/or require intervention include, but are not limited to aneurysm enlargement.¿.
Event or Problem Description
On (b)(6) 2011, the patient was implanted with a gore® tag® thoracic endoprosthesis to treat a dissecting descending thoracic aortic aneurysm.A gore® excluder® aortic extender component (pxa260300/8641521) was separately implanted to cover an entry tear proximal to the celiac artery.On an unknown date in 2018, follow-up examination reportedly revealed the false lumen was enlarged around the aortic extender component.On (b)(6) 2018, a re-intervention was performed whereby an additional conformable gore® tag® thoracic endoprosthesis was implanted distally.The patient tolerated the procedure.

• 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: 7940531
• Report Number: 2953161-2018-00089
• Device Sequence Number: 1998658
• Product Code: MIH
• UDI-Device Identifier: 00733132609888
• UDI-Public: 00733132609888
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2018

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: 11/30/2013
• Device Catalogue Number: PXA260300
• Device Lot Number: 8641521
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2018
• 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: 74 YR