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

Model Number IRS47045L

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hematoma (1884)

Event Date 03/16/2021

Event Type  Injury  

Event Description

The following information was reported to gore: on (b)(6) 2021, a gore® intering® vascular graft was intended for hemodialysis treatment.On (b)(6) 2022, the patient presented with seroma.A gore® intering® vascular graft was sewn in as a interposition graft.On (b)(6) 2022, the patient presented with seroma.A gore® viabahn® endoprosthesis (vsx device) was endovascularly placed to reline the second gore® intering® vascular graft, for treatment of ultrafiltration.Ultrafiltration was identified during the procedure after the vsx device was successfully implanted.On (b)(6) 2022, the gore® intering® vascular graft, and vsx device were explanted.(b)(4).

Manufacturer Narrative

Manufacturing records were reviewed, and the device met all pre-release specifications.An evaluation of the device could not be conducted because no specimen returned.Consequently, a direct product analysis was not possible.Cause of the reported event cannot be established based on evaluation of the information reported to gore.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.

• Brand Name: GORE® INTERING® VASCULAR GRAFT
• Type of Device: 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14603491
• MDR Text Key: 293364612
• Report Number: 2017233-2022-02987
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132607204
• UDI-Public: 00733132607204
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IRS47045L
• Device Catalogue Number: IRS47045L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2020
• 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): Hospitalization; Other; Required Intervention