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

Catalog Number	PXT281414
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional manufacturer narrative/corrected data - the gore® excluder® aaa endoprosthesis aortic extender component is reported on mfr report #2017233-2019-01225.
Event or Problem Description
On (b)(6) 2012, this patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.The patient was then lost to follow up.The patient returned for follow up in (b)(6) 2017 with an aneurysm rupture and a type 1a endoleak, and a 32mm gore® excluder® aaa endoprosthesis aortic extender component and endurant cuff were placed.The patient improved after the treatment, however the aneurysm continued to increase due to a persistent type 1a endoleak.Therefore in (b)(6) 2018, endo-anchors were placed.However, the aneurysm continued to increase.In (b)(6) 2019, the endoleak was treated with glue and coil embolization of the inferior mesenteric artery.In (b)(6) 2019, follow up revealed the aneurysm had increased by another 3mm.

• 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: 9438449
• Report Number: 2017233-2019-01224
• Device Sequence Number: 2353401
• Product Code: MIH
• UDI-Device Identifier: 00733132610303
• UDI-Public: 00733132610303
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 11/11/2019

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: 01/31/2014
• Device Catalogue Number: PXT281414
• Device Lot Number: 8792998
• 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: 12/09/2019
• 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: Other; Required Intervention
• Patient Age: 88 YR
• Patient Weight: 88