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

Model Number	RLT261416
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Codes	Bacterial Infection (1735); Fungal Infection (2419)
Date of Event	01/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: gore® excluder® aaa endoprosthesis - stent graft contralateral leg endoprosthesis (b)(4).Gore® excluder® aaa endoprosthesis - stent graft aortic extender endoprosthesis (b)(4).(b)(4).
Event or Problem Description
On (b)(6) 2015, a patient presented with an abdominal aortic aneurysm (measured 50.6 mm) was treated with gore® excluder® aaa endoprosthesis (b)(4).On (b)(6) 2021, the patients was admitted with type ii endoleak and a sudden growth of the aneurysmal sac (80 mm).The endoleak was embolized with some metallic spiral and glue.This event was reported separately with manufacturer report number 3007284313-2022-02017.After the procedure the patient started with a fever and covid positive results and was moved to covid ward.After the flogistic index continues to be high a month later, an antibiotic therapy and infective consultation was initiated.On (b)(6) 2022, after a missed clinical improvement a pet scan was performed that confirmed infection of stent graft.It was reported that it is not possible to confirm if the infection is related to the embolization or due to prior illnesses.On (b)(6) 2022, the patient underwent conversion and received a biological graft replacement.The explanted gore® excluder® aaa endoprosthesis tested positive for staphylococcus capitis and staphylococcus lugdunensis, postoperative hemoculture tested positive for candida albicans.On (b)(6) 2022, it was reported that the patient was discharged at home.
Additional Manufacturer Narrative
A review of the manufacturing and sterilization records indicated the lot met all pre-release manufacturing specifications.Per gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: infection (e.G., aneurysm, device or access sites).This device is also reported with the manufacturer report number 3007284313-2022-02017 (for the reintervention on december 1, 2021).Updated investigation findings code to 213 - no device problem found.Code 3233 is no longer applicable.Updated investigation conclusions code to 4315 and 22.Code 11 is no longer applicable.

• 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: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14943462
• Report Number: 3007284313-2022-02018
• Device Sequence Number: 6196633
• Product Code: MIH
• UDI-Device Identifier: 00733132622467
• UDI-Public: 00733132622467
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2022

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: 11/30/2017
• Device Model Number: RLT261416
• Device Catalogue Number: RLT261416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2014
• 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: SEE H10
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Race: White