MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE-TEX® STRETCH VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Model Number	SB2201D
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	09/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to gore that the patient underwent surgical treatment for a subrenal abdominal aortic aneurysm with a gore-tex® stretch vascular graft ¿ standard-walled bifurcated.It was stated that the prosthesis was implanted as an aorto-biiliac bypass during a robotic-assisted surgery on (b)(6) 2020.It was reported that on (b)(6) 2021, after about 9 months, the prosthesis was explanted due to an infection to streptococcus anginosus.
Additional Manufacturer Narrative
Analysis-report from third party was received and will be further investigated.(b)(4).
Additional Manufacturer Narrative
Explant investigation: the device was returned to geprovas for investigation.Submitted in formalin was a gore-tex® stretch vascular graft (standard wall bifurcated).The scope and results of the investigation were summarized and a report was submitted to w.L.Gore & associates.An explant scientist at w.L.Gore & associates reviewed the report.Explant scientist observations: the abluminal surface was generally devoid of tissue, except for scattered plaques of dark brown/red tissue.Red/brown and tan tissue were present in the lumen.The lumen did not appear to be occluded; however, the luminal patency could not be determined with the information/images provided.White, monofilament, broken sutures in a running pattern with anastomotic suturing holes were present at the proximal extremity and distal extremity b.The broken sutures and suturing holes were consistent with anastomotic suturing that had been cut by a sharp surgical instrument (i.E., scissors), likely during a surgical procedure.All the extremity edges were transected.The transections were consistent with cutting via sharp surgical instrumentation (i.E., scalpel/scissors), likely used during a surgical procedure.One leg presented in a kinked manner.Material disruptions (i.E., broken suture, suturing holes, transections) were consistent with those caused by interaction with surgical instrumentation (i.E., suturing needle, scalpel/scissors), likely used during a surgical procedure.Request for additional analysis: no reason: based on the explant scientist¿s review of the geprovas report and reason for removal (infection), no additional analysis is requested.In the instruction for use for the gore-tex® stretch vascular graft the following is stated: possible complications with the use of any vascular prosthesis complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: infection.

• Brand Name: GORE-TEX® STRETCH VASCULAR GRAFT
• Common Device Name: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14201314
• Report Number: 2017233-2022-02883
• Device Sequence Number: 13897749
• Product Code: DSY
• UDI-Device Identifier: 00733132611881
• UDI-Public: 00733132611881
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K904282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2022

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: 11/17/2024
• Device Model Number: SB2201D
• Device Catalogue Number: SB2201D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2019
• 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: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male