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

Model Number	PLC201400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: plc271000/14082238, udi: (b)(4).Of the contralateral leg components implanted on july 21, 2016, it is unknown which component was implanted on which side.Please reference mfr report #2953161-2020-00010.
Event or Problem Description
On (b)(6) 2016, this patient underwent endovascular treatment for an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.On (b)(6) 2020, bilateral type ib endoleaks were discovered.The endoleaks were caused by bilateral degenerative iliac disease.On (b)(6) 2020, a reintervention occurred to treat the endoleaks.On the left side, coil embolization of the left internal iliac artery was performed along with an implant of a contralateral leg component to extend distally to the left external iliac artery.On the right side, a retrograde implant of an ibe device was performed (off label) to extend and bridge the previously implanted contralateral leg component.

• 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: 9889324
• Report Number: 2953161-2020-00009
• Device Sequence Number: 16960842
• Product Code: MIH
• UDI-Device Identifier: 00733132618552
• UDI-Public: 00733132618552
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/26/2020

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: 09/30/2018
• Device Model Number: PLC201400
• Device Catalogue Number: PLC201400
• Device Lot Number: 14398552
• 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: 03/27/2020
• 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: Other; Required Intervention
• Patient Age: 74 YR