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

Model Number	S0504
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Seroma (2069); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was requested from the hospital, but has not been received yet.A review of the manufacturing records indicated the lots met all pre-release specifications.
Event or Problem Description
It was reported to gore that the patient underwent surgical procedure for a fistula in the arm with a gore-tex® stretch vascular graft.It was stated that the patient was operated a second time because of a still existing lymphocele.The physician decided to explant the device and to implant a device from another manufacturer.The patient tolerated the procedure.
Additional Manufacturer Narrative
Product history review: a review of the manufacturing records indicated the lots met all pre-release specifications.As the device was discarded at the hospital, no further investigation of the device can be conducted.Neither clinical images enabling direct assessment of product performance nor the product itself were returned for evaluation.With the information provided to gore, the cause of the reported issue 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: ultrafiltration or perigraft seroma.

• 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: 12877891
• Report Number: 2017233-2021-02571
• Device Sequence Number: 4472824
• Product Code: DSY
• UDI-Device Identifier: 00733132611232
• UDI-Public: 00733132611232
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K903931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2022

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: 05/05/2026
• Device Model Number: S0504
• Device Catalogue Number: S0504
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2021
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 11/26/2021
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2021
• 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 Sex: Male