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

Model Number	PLC231000
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2006, this patient underwent open surgery and was implanted with a prostheses to treat an abdominal aortic aneurysm.On (b)(6) 2016, an additional endovascular treatment with gore® excluder® aaa endoprostheses was performed after follow-up imaging on an unknown date had identified suture related distal anastomotic aneurysms.On that day, the patient was reportedly implanted with a gore® excluder® trunk-ipsilateral leg component rlt231412, and with two gore® excluder® contralateral leg components, plc231000 and plc27100.On (b)(6) 2020, follow-up imaging revealed an aneurysm of the left common iliac artery measuring 46 mm in diameter due to disease progression distal to the contralateral leg component plc231000.It was also noted that the component now showed a type 1b endoleak that reportedly was believed to have been caused by the developing aneurysm.The common iliac artery on the right appeared to be expanded but showed no aneurysm requiring treatment.On (b)(6) 2020, a reintervention was performed to treat the aneurysm on the left together with the endoleak and the plc231000 endoprosthesis was extended with a gore® excluder® iliac branch component ceb231410.Additionally, the contralateral side of the ceb component was extended with a gore® viabahn® vbx balloon expandable endoprosthesis.The patient tolerated the procedure.
Additional Manufacturer Narrative
H6: code 213 - the review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.H6, health effect - impact code: added codes 4642 and 4625.H6, component code: added code 515.H6, investigation conclusions: added code 22.Code 22: according to the gore® excluder® aaa endoprosthesis instructions for use (ifu) adverse events that may occur and/or require intervention include, but are not limited to: aneurysm enlargement, 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
• Manufacturer (Section G): MEDICAL SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: thomas giebing ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11180871
• Report Number: 2953161-2021-01039
• Device Sequence Number: 11499862
• Product Code: MIH
• UDI-Device Identifier: 00733132618576
• UDI-Public: 00733132618576
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2022

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: 09/30/2018
• Device Model Number: PLC231000
• Device Catalogue Number: PLC231000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 60 KG