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

Model Number	PLC201400
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
Date of Event	08/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report also includes plc201200/(b)(4)/(b)(4).
Event or Problem Description
On (b)(6) 2015, the patient was treated for an abdominal aortic aneurysm.A gore® excluder® aaa endoprosthesis featuring c3® delivery system and two gore® excluder® aaa endoprostheses were implanted.The patient tolerated the procedure.On (b)(6) 2020, follow up revealed a distal type i endoleak due to one of the gore® excluder® aaa endoprostheses migrating proximally.The physician believes this is due to disease progression, as the device implanted was 20mm in diameter, and the left common iliac is now 25-28mm in diameter.A reintervention is planned.Further information from the fsa reported that the planned reintervention took place on (b)(6) 2020.An additional gore® excluder® aaa endoprosthesis was implanted, and the physician reinforced it with a palmaz stent.The endoleak was resolved and the patient tolerated the procedure.
Additional Manufacturer Narrative
H6: code 213 - the review of the manufacturing paperwork verified that this lot met all pre-release specifications; h6: code 22 ¿ 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.
Additional Manufacturer Narrative
H6: code 3331 - added with completion of product history review.

• Brand Name: GORE EXCLUDER AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10483013
• Report Number: 3007284313-2020-01054
• Device Sequence Number: 2815965
• Product Code: MIH
• UDI-Device Identifier: 00733132618552
• UDI-Public: 00733132618552
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2020

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: 08/31/2017
• Device Model Number: PLC201400
• Device Catalogue Number: PLC201400
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 08/13/2020; 08/13/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 09/21/2020; 09/21/2020
• 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: 57 YR