MAUDE Adverse Event Report: CRYOLIFE, INC.; HEART-VALVE, MECHANICAL

Catalog Number AV00-23

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2020

Event Type  malfunction  

Event Description

The graft fell apart.

• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd nw; kennesaw GA 30144
• MDR Report Key: 10487551
• MDR Text Key: 205490947
• Report Number: 10487551
• Device Sequence Number: 1
• Product Code: LWQ
• 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: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: AV00-23
• 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: 07/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27010 DA