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

Device Problem Material Integrity Problem (2978)

Patient Problems Seroma (2069); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2021

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 281274171
• Report Number: 2017233-2021-02571
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132611232
• UDI-Public: 00733132611232
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K903931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: S0504
• Device Catalogue Number: S0504
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male