MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	RLT351416
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The following information was reported to gore: on (b)(6) 2013, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was treated with gore® excluder® aaa endoprostheses.Pre-operative imaging revealed a maximum aneurysm diameter of 61 mm.On (b)(6) 2014, computed tomography angiography (cta) imaging revealed a type ii endoleak from the lumbar arteries.Between (b)(6) 2014, and (b)(6) 2015, cta imaging confirmed a maximum aneurysm diameter increase of 10 mm as 48 and 58 mm were measured at those time points with an ongoing type ii endoleak.On (b)(6) 2015, the type ii endoleak was embolized.On (b)(6) 2016, the same type ii endoleak was noted to be active again and it was decided to surveil the patient.On (b)(6) 2018, cta imaging findings identified an aneurysm diameter of 67 mm and a type ii endoleak.On (b)(6) 2018, the endoleak was embolized.A follow-up visit has been scheduled with the patient to verify successful embolization.
Additional Manufacturer Narrative
Age at time of event: updated/corrected.Date of event: updated/corrected.Describe event or problem: updated/corrected.
Event or Problem Description
On (b)(6) 2016, the same type ii endoleak was noted to be active again and it was decided to surveil the patient.On (b)(6) 2017, cta imaging showed an aneurysm diameter of 55 mm without a type ii endoleak.Therefore, the endoleak was considered resolved.On (b)(6) 2018, cta imaging findings identified an aneurysm diameter of 67 mm and a type ii endoleak.On (b)(6) 2018, the endoleak was embolized.A follow-up visit has been scheduled with the patient to verify successful embolization.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7645819
• Report Number: 2017233-2018-00358
• Device Sequence Number: 1551229
• Product Code: MIH
• UDI-Device Identifier: 00733132618484
• UDI-Public: 00733132618484
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2018

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: 07/31/2016
• Device Catalogue Number: RLT351416
• Device Lot Number: 11776349
• 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: 06/28/2018
• Supplement Report FDA Received Date: 08/21/2018
• 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: 64 YR