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

Model Number	PXT261218
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
Date of Event	08/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report also includes (b)(4).
Event or Problem Description
Following was reported to gore: on (b)(6) 2012, a patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.On an unknown date, a ct imaging revealed aneurysm enlargement approximately 20mm, and a type ii endoleak from inferior mesenteric artery was suspected.In (b)(6) 2020, coil embolization was performed to treat the type ii endoleak.The patient tolerated the procedure.(above event was reported under mpdcase-(b)(4)).On an unknown date, a type iii endoleak(unknown whether component disconnection nor tear/disruption in graft material) and a type ii endoleak was suspected from a imaging.On (b)(6) 2020, re-intervention placing additional stent graft at the connection of the (b)(4) was performed.The physician elected to monitor type ii endoleak, and no treatment was performed for type ii endoleak.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.

• 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: 10488929
• Report Number: 2953161-2020-01017
• Device Sequence Number: 19531853
• Product Code: MIH
• UDI-Device Identifier: 00733132610204
• UDI-Public: 00733132610204
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 07/31/2014
• Device Model Number: PXT261218
• Device Catalogue Number: PXT261218
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 09/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR