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

Model Number	PXT261414
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	03/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This event also includes device (b)(4).
Event or Problem Description
On (b)(6) 2009, the patient was treated for an aortic abdominal aneurysm.Six excluder devices were implanted, and the patient tolerated the procedure.On (b)(6) 2021, the patient was treated emergently for a ruptured aneurysm.It was determined that a type iii endoleak had occurred between two components, allowing the aneurysm to expand and rupture.A gore® excluder® aaa endoprosthesis was place in the gap between the two separated devices.After successfully placing the device, as the delivery catheter was being removed, the olive tip separated from the catheter.The physician was able to retrieve the olive, and the patient tolerated the procedure.The delivery catheter will be returned for evaluation.

• 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: 11638050
• Report Number: 2017233-2021-01852
• Device Sequence Number: 3697600
• Product Code: MIH
• UDI-Device Identifier: 00733132610228
• UDI-Public: 00733132610228
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2021

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: 09/30/2010
• Device Model Number: PXT261414
• Device Catalogue Number: PXT261414
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 04/08/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR