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

Catalog Number	PXC121000
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the instructions for use (ifu) for the gore® excluder® aaa endoprostheses featuring c3® delivery system, adverse events that may occur include, but are not limited to include: endoleak and reintervention.
Event or Problem Description
On (b)(6) 2016, this patient underwent endovascular treatment and was implanted with gore® excluder® aaa endoprostheses featuring c3® delivery system.The patient tolerated the procedure.On (b)(6) 2019, follow up imaging determined a possible unknown endoleak.Images were provided to gore and an evaluation showed the following: images provided are post-implant cta dated (b)(6) 2019, arterial phase.A non-contrast phase was submitted but missing images, only a couple are provided for comparison.There appears to be a lack of wall apposition at the distal end of the device on the right.There appears to be contrast pooling outside of the distal end of the device on the right.There appears to be contrast pooling in the sac at the level of the implanted device.There appears to be patent lumbar present at the level of the implanted device.This may or may not be associated with a possible type ii endoleak.Findings are consistent with a distal type i endoleak.On (b)(6) 2019 the patient underwent a reintervention to treat the distal type i endoleak.Coils were placed in the right internal iliac artery, and a contralateral leg component (plc1612007/18460915) was placed as an extension into the right iliac artery.The endoleak was resolved and 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: 8745602
• Report Number: 3013164176-2019-00074
• Device Sequence Number: 1330118
• Product Code: MIH
• UDI-Device Identifier: 00733132609918
• UDI-Public: 00733132609918
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/06/2019

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: 03/08/2019
• Device Catalogue Number: PXC121000
• Device Lot Number: 14848412
• 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: 06/28/2019
• 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: 82 YR