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

Model Number	PLC121400
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional medical device involved in this case that was extended on the left side: gore® excluder® contralateral leg component plc161200 / (b)(4).The review of the manufacturing records verified that the lots involved in this event met all pre-release specifications.
Event or Problem Description
On (b)(6) 2020, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was treated with gore® excluder® aaa endoprostheses.On (b)(6) 2021, follow-up computed tomography imaging reportedly appeared to show a potential infection around the graft.It was also reported that there was a suspected type 1b endoleak.Due to the graft infection, a slight enlargement of the aneurysm sac could not be definitely determined.However, the patient was reported to have been asymptomatic.On (b)(6) 2021, a re-intervention was performed to treat the suspected type 1b endoleak.On the right patient side, the previously implanted gore® excluder® contralateral leg component plc121400 was extended with a gore® excluder® iliac extender component pll161407.Also, the gore® excluder® contralateral leg component plc161200 initially implanted on the left was extended with a gore® excluder® contralateral leg component plc141200.During the re-intervention, the left internal iliac artery was additionally embolized.
Additional Manufacturer Narrative
B5: updated event description.H6: health effect - impact code: added code 4625.H6: component code: added code 515.H6: type of investigation: added code 4111.H6: investigation conclusions: added codes 4315, 22.H6, 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: endoleak.H6: health effect - impact code: retracted code 4642.
Event or Problem Description
On (b)(6), 2020, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was treated with gore® excluder® aaa endoprostheses.On (b)(6), 2021, follow-up computed tomography imaging reportedly appeared to show a type 1b endoleak as well as an infection around the graft with a slight enlargement of the aneurysm sac.A bacterial infection of the grafts was reportedly assumed and ongoing with the patient likely having received antibiotic treatment.The amount of growth was difficult to determine due to the infected state of the aneurysm but was reportedly believed to be less than 5 mm.However, there was no additional information of cause, type, treatment, and current state of the infection available and there reportedly had not been any other diagnoses that confirmed the infection.Also, the patient was reported to have been asymptomatic.On (b)(6), 2021, a re-intervention was performed and the suspected type 1b endoleak of the gore® excluder® contralateral leg component plc161200 initially implanted on the left was extended with a gore® excluder® contralateral leg component plc141200.Additionally, the left internal iliac artery was embolized.On the right patient side, the previously implanted gore® excluder® contralateral leg component plc121400 was likewise extended with a gore® excluder® iliac extender component pll161407 as a preventive measure against a potential formation of an endoleak on this side.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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: thomas giebing ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11567051
• Report Number: 3013164176-2021-01141
• Device Sequence Number: 11643036
• Product Code: MIH
• UDI-Device Identifier: 00733132618644
• UDI-Public: 00733132618644
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2022

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: 06/09/2022
• Device Model Number: PLC121400
• Device Catalogue Number: PLC121400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2019
• 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: Hospitalization; Disability
• Patient Age: 77 YR
• Patient Sex: Male