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

Model Number	RLT231414
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	09/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented on (b)(6) 2015 with an abdominal aortic aneurysm that was treated with gore® excluder® aaa endoprostheses.It was stated that on (b)(6) 2020, device infection of the implanted endoprostheses was identified.No further information was provided.
Event or Problem Description
It was reported that on (b)(6) 2015, the patient presented with an abdominal aortic aneurysm that was treated with gore® excluder® aaa endoprostheses.It was stated that on (b)(6) 2020, device infection of the implanted endoprostheses was identified.The physician stated the patient had recent gastroenteritis caused by campylobacter fetus.The same germen was found in the endograft and the blood culture.On (b)(6) 2020, the devices were explanted and a bypass using pericardial bovine paths was performed.The patient tolerated the procedure and was discharged on (b)(6) 2020.
Additional Manufacturer Narrative
H6: code 213 - the review of the manufacturing/sterilization paperwork verified that this lot met all pre-release specifications.

• 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
• MDR Report Key: 10683391
• Report Number: 3007284313-2020-01111
• Device Sequence Number: 11472224
• Product Code: MIH
• UDI-Device Identifier: 00733132622375
• UDI-Public: 00733132622375
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2018
• Device Model Number: RLT231414
• Device Catalogue Number: RLT231414
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2020
• Supplement Date Received by Manufacturer: 09/19/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PXL161007/14172584, PLC231200/14189848.; PXL161007/14172584, PLC231200/14189848
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 85