MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	RLT261218
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Codes	Bacterial Infection (1735); No Code Available (3191)
Date of Event	03/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.
Event or Problem Description
It was reported that on (b)(6) 2016, the patient presented with bilateral iliac aneurysms and was treated with gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses on the patients left.On an unknown date in (b)(6) 2019 the patient admitted for a left psoas abscess.In (b)(6) 2019, a percutaneous drainage revealed a staphylococci infection.A positron-emission tomography (pet) showed infection of all excluder components.On (b)(6) 2019, all components were successfully explanted and a synergy antimicrobial graft was successfully implanted.Intraoperative samples found staphylococcus aureus, staphylococcus warneri, corynebacterium.It was stated that 6 months post-op, the leucocyte count and crp values were normal and that the renal function was at pre-op level.The 6-month routine pet-ct revealed no signs of reinfection.
Additional Manufacturer Narrative
B3: updated / only the month on which the infection was identified is known.Therefore march 01, 2019 was used as the event date.E2: updated h6: updated code 213 - the review of the manufacturing and sterilization paperwork verified that this lot met all pre-release specifications.Code 22: the gore® excluder® aaa and gore® excluder® iliac branch endoprostheses (ibe)instructions for use (ifu) mentions adverse events that may occur and/or require intervention include, but are not limited to infection (e.G., aneurysm, device or access sites).

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9763229
• Report Number: 3007284313-2020-00057
• Device Sequence Number: 504756
• Product Code: MIH
• UDI-Device Identifier: 00733132622436
• UDI-Public: 00733132622436
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2020

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: 01/26/2019
• Device Model Number: RLT261218
• Device Catalogue Number: RLT261218
• Device Lot Number: 14713932
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 07/14/2020
• 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: PLC271000/14759355
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 82