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

Model Number	PLC231000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use, adverse events with may occur and/or require intervention including, but not limited to, endoleak and aneurysm rupture.See also mfg report# 3013164176-2020-00034 for ceb231210a lot# 18595633 udi (b)(4).
Event or Problem Description
On an unknown date in (b)(6) 2019, the patient was implanted with a gore® excluder® iliac branch endoprosthesis and two gore® excluder® aaa endoprostheses to treat an aortic aneurysm in the right internal iliac.The patient reported emergently on (b)(6) 2019, with a contained iliac rupture.The rupture was caused by a disconnect between the gore® excluder® iliac branch endoprosthesis and one of the gore® excluder® aaa endoprostheses.A plc271400 was used to reline the area of the disconnect.The patient tolerated the procedure.
Additional Manufacturer Narrative
H10/11: narrative/corrected data - gore is unable to determine which gore® excluder® aaa endoprosthesis was involved in this event.Plc231200/18144849 will also be included in this report.

• 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: 9812187
• Report Number: 3013164176-2020-00035
• Device Sequence Number: 3002885
• Product Code: MIH
• UDI-Device Identifier: 00733132618576
• UDI-Public: 00733132618576
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2020

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: 08/20/2021
• Device Model Number: PLC231000
• Device Catalogue Number: PLC231000
• Device Lot Number: 18495861
• 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: 03/10/2020
• Supplement Report FDA Received Date: 04/27/2020
• 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: Required Intervention
• Patient Age: 75 YR