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

Model Number	PLC231400
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), users are made aware of the risks associated with type ii endoleaks and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.Additionally, per ifu, adverse events that may occur and / or require intervention include, but are not limited to endoleak and aneurysm enlargement.  the patient referenced in this report is enrolled in a post market study to grt 10-11 evaluation of the gore® excluder® aaa endoprosthesis c3 delivery system through the global registry for endovascular aortic treatment (great), the clinical data management system (cdms), is medidata rave® clinical study database (csd), grt 10-11 module.The study involves commercially available devices marketed by gore.
Event or Problem Description
It was reported that on (b)(6) 2014, the patient presented with an abdominal aortic aneurysm that was treated with gore® excluder® aaa endoprosthesis (pre-implant ct diameter 65 mm).On (b)(6) 2021, a type ib endoleak was treated with the implantation of an additional aortic endograft ((b)(6) 2021 ct diameter: 105 mm).The patient tolerated the procedure.
Additional Manufacturer Narrative
H6: component code 515 added.
Additional Manufacturer Narrative
A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.Additional information on the cause of the endoleak has been requested but was not provided.The cause of the reported complications may be the result of the patient¿s disease progression or disease symptoms, co-morbidities and conditions and surgical technique, however no further information related to this was reported to gore.H6: added additional conclusion code.
Event or Problem Description
It was reported that (b)(6) 2014, the patient presented with an abdominal aortic aneurysm that was treated with gore® excluder® aaa endoprosthesis (pre-implant ct diameter 65 mm).It was reported that on (b)(6) 2019, a distal type ib endoleak was identified (ct diameter 86 mm).On (b)(6) 2021, a type ib endoleak was treated with the implantation of an additional aortic endograft ((b)(6) 2021 ct diameter: 105 mm).The patient tolerated the procedure.

• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: joerg kersten ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12861938
• Report Number: 3007284313-2021-01674
• Device Sequence Number: 4317212
• Product Code: MIH
• UDI-Device Identifier: 00733132618583
• UDI-Public: 00733132618583
• 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: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2022

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: 11/30/2016
• Device Model Number: PLC231400
• Device Catalogue Number: PLC231400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 01/27/2022; 01/27/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 01/27/2022; 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2013
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RMT281416/(B)(6) , PLC231000/(B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 87 KG