MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE-TEX® STRETCH VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number	SBT1602D
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	11/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis-report from third party was received and will be further investigated.
Event or Problem Description
It was reported to gore that patient underwent endovascular treatment for a ruptured aneurysm of the abdominal aorta with a gore-tex® stretch vascular graft - thin-walled bifurcated.It was stated that the prosthesis was implanted on (b)(6) 2020 as an aorto-bi-iliac bypass.Reportedly, on (b)(6) 2020, after about 2 months and 7 days, the prosthesis was explanted due to infection to methicillin-resistant staphylococcus aureus and enterococcus faecalis.
Additional Manufacturer Narrative
Phr-review: a review of the manufacturing records indicated the lots met all pre-release specifications.  explant investigation (ei) of the gore-tex® stretch vascular graft.The following is a summary of the ei observations: tissue present: yes.The abluminal surface was generally devoid of tissue, except for multifocal areas tan and brown tissue.A large foci of dark brown/red tissue was also present, on the abluminal surface of the main body of the graft fragment.The lumen was generally devoid of tissue and reported as ¿clear¿ by third party.The extremity luminal images presented a clear and patent lumen.However, the luminal patency could not be determined with the information provided.All three extremities were transected.Extremity a was partially invaginated toward the lumen, which was reported as potentially caused by storage conditions via third party.An area with multiple, mono-filament, blue suture was present near extremity a.Material disruptions (i.E., transections, sutures, invagination) are consistent with those caused by surgical instrumentation (i.E., scalpel/scissors, suturing needle) or device storage conditions, likely used during a surgical procedure.Request for additional analysis: no.Reason: based on the ei¿s review of the third party report and reason for explant (infection), no additional analysis is requested.
Additional Manufacturer Narrative
H6 evaluation codes investigation findings 213 refers to the product history review: a review of the manufacturing and sterilization records indicated the lots met all pre-release specifications.  further information was requested from the physician, like how was the infection identified, was this a systemic bacterial infection, are bacteriology findings available that confirm the infection, what caused the infection, did the patient have a history of pre-existing infection in the field of treatment, and if the infection was caused or contribute by the gore devices and/or the procedure to implant devices, however no further information was provided.With the information provided to gore, the cause of the reported event cannot be established.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, OF 6MM AND GREATER DIAMETER
• 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: 11027116
• Report Number: 2017233-2020-01539
• Device Sequence Number: 3477722
• Product Code: DSY
• UDI-Device Identifier: 00733132612024
• UDI-Public: 00733132612024
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2022

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: 05/04/2025
• Device Model Number: SBT1602D
• Device Catalogue Number: SBT1602D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 09/14/2021; 04/26/2022
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 10/08/2021; 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2020
• 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: 79 YR
• Patient Sex: Female