MAUDE Adverse Event Report: W. L. GORE ASSOCIATES, INC. GORE PROPATEN VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number H470045A

Patient Problem Failure of Implant (1924)

Event Date 06/29/2023

Event Type  malfunction  

Event Description

From staff: md performing av fistula creation via propaten graft.Md was tunneling with graft to prepare for anastomosis.During tunneling, a small hole ripped within the graft itself and was caught by the md.Graft was removed from the patient and given to the circulating rn for risk management to evaluate.New graft was used with no issues.

• Brand Name: GORE PROPATEN VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): W. L. GORE ASSOCIATES, INC.; 1505 north fourth street; flagstaff AZ 86004
• MDR Report Key: 17497516
• MDR Text Key: 320769685
• Report Number: 17497516
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H470045A
• Device Catalogue Number: H470045A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Sex: Female
• Patient Weight: 94 KG