MAUDE Adverse Event Report: CRYOLIFE, INC.; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Catalog Number L1223.034

Device Problem Output Problem (3005)

Patient Problem Stenosis (2263)

Event Date 07/22/2022

Event Type  malfunction  

Event Description

Thawed a cryovein for the procedure and once it was thawed and we examined the vein it was not good, it had a stenosis in the center of the vein.

• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd nw; kennesaw GA 30144
• MDR Report Key: 15292797
• MDR Text Key: 298594759
• Report Number: 15292797
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: L1223.034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1