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

Model Number PXT261218

Device Problem Migration (4003)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 08/01/2020

Event Type  Injury  

Manufacturer Narrative

Report also includes (b)(4).

Event 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.

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
• Type of Device: 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
• MDR Text Key: 208130088
• Report Number: 2953161-2020-01017
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132610204
• UDI-Public: 00733132610204
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2014
• Device Model Number: PXT261218
• Device Catalogue Number: PXT261218
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 08/12/2020
• Supplement Dates FDA Received: 09/21/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR