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

Catalog Number	PLC121200
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Gore® excluder® iliac branch endoprosthesis, hgb161207, lot# 18104194, udi: (b)(4), is being reported separately.A review of the manufacturing records for the devices verified the lots met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to endoleaks.Additionally it states, the device has not been evaluated for use in the revision of previously placed stent grafts.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018, a patient was undergoing a reintervention to reline a cook zenith limb due to disease progression, resulting in a type 1b endoleak.A gore® excluder® iliac branch endoprosthesis was implanted in the gate of the cook device.Then a gore® excluder® aaa endoprosthesis was utilized to extend from the iliac branch component into the external iliac artery with an estimated 3cm of overlap between these devices.Following deployment, a coda balloon was advanced and inflated.However, during ballooning, there appeared to be some movement of the overlap of the two components with reduction of the overlap, but it was not seen as significant.On (b)(6) 2018 a follow-up cta revealed further reduction of the overlap between the gore® excluder® iliac branch endoprosthesis and the gore® excluder® aaa endoprosthesis.A reintervention took place to treat this type iii endoleak whereby an additional gore® excluder® aaa endoprosthesis was positioned and deployed.A coda balloon was inflated within the device and the final angio run showed resolution of the type iii endoleak.

• 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: 8096677
• Report Number: 3013164176-2018-00114
• Device Sequence Number: 2791681
• Product Code: MIH
• UDI-Device Identifier: 00733132618712
• UDI-Public: 00733132618712
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/16/2018

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: 06/12/2021
• Device Catalogue Number: PLC121200
• Device Lot Number: 18241056
• 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: 11/21/2018
• 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; Other; Required Intervention
• Patient Age: 84 YR