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

Catalog Number	RLT261218
Medical Device Problem Codes	Use of Device Problem (1670); Malposition of Device (2616)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	02/14/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
A presentation with the title ¿bilateral use of the gore ibe device for bilateral cia aneurysms and a first interim analysis of the prospective iceberg registry¿ was held by dr.M.Reijnen at the linc convention on january 21, 2019.The presentation included initial results of the ongoing iceberg study that included 101 patients at eight international sites that were treated with gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses (ibe).Among other occurrences, the presentation mentions that partial coverage of a renal artery with stenting of the renal artery occurred during the implant procedure.It was not indicated that the partial coverage was unintentional.The following additional info was reported to gore april 19, 2019: patient (b)(6) was treated on (b)(6) 2017.According to the physician the gore® excluder® aaa trunk - ipsilateral leg endoprosthesis (rlt) was accidently pushed proximal due to advancement difficulties of the left bridging stent on the left side.The rlt covered the left renal artery partially (50%), which was successfully solved by implanting a 7mm balloon expandable covered stent in the renal artery.

• 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: 8615472
• Report Number: 3007284313-2019-00145
• Device Sequence Number: 16952920
• Product Code: MIH
• UDI-Device Identifier: 00733132622436
• UDI-Public: 00733132622436
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2019

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: 09/01/2019
• Device Catalogue Number: RLT261218
• Device Lot Number: 15440234
• 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: 05/16/2019
• Supplement Report FDA Received Date: 08/08/2019
• 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: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 80