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

Catalog Number	RMT231214
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/11/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore: the endograft was implanted in (b)(6) 2014 as an aorto-bi-iliac bypass in order to treat an uncomplicated abdominal aortic aneurysm.On (b)(6) 2015, the endograft was explanted due to a type ii endoleak.
Additional Manufacturer Narrative
Date of event: updated.Event description: updated.If implanted, give date: added date.If explanted, give date: corrected date.Code 213 - the review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.Code 22 - according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), complications associated with the use of the gore® excluder® aaa endoprosthesis may include but are not limited to: endoleaks.Both the explanted gore® excluder® trunk-ipsilateral leg component rmt231214/11889297 and the gore® excluder® contralateral leg component pxc141200/11922062 were returned to geprovas for investigation.Tissue was present.Scattered plaques of dark red/brown and yellow/tan tissue were observed on the abluminal surfaces.Minimal plaques of red/brown tissue were present on the luminal surfaces.All lumens appear widely patent when looking in from the poles.Lumen patency for the entire device could not be determined with the information provided.Segments 1 and 2 consisted of tan/brown tissue, which was not adherent to the devices.The contralateral leg component was contained within the contralateral gate of the trunk.From gross images, no material disruptions were identified.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2014, this patient underwent endovascular treatment for uncomplicated abdominal aortic aneurysm and was therefore treated with gore® excluder® aaa endoprostheses.On an unknown date in march 2016, follow-up imaging revealed a type ii endoleak.On an unknown date in 2017, follow-up imaging identified an aneurysm enlargement with a diameter measuring 54x44 mm.Reportedly, the amount of the aneurysm increase was unknown.On (b)(6) 2018, the endoprothesis were explanted due to the type ii endoleak.

• 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: 8247563
• Report Number: 2017233-2019-00033
• Device Sequence Number: 1593508
• Product Code: MIH
• UDI-Device Identifier: 00733132610518
• UDI-Public: 00733132610518
• 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: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2019

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: 09/30/2016
• Device Catalogue Number: RMT231214
• Device Lot Number: 11889297
• 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: 01/15/2019
• Supplement Report FDA Received Date: 06/12/2019
• 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: 73 YR