MAUDE Adverse Event Report: CORMATRIX CARDIOVASCULAR, INC.; PATCH, PLEDGET, INTRACARDIAC

Catalog Number CMCV-003-402

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 12/16/2013

Event Type  malfunction  

Event Description

Cormatrix cardiac patch dehisced, which required replacement of mitral valve.

• Type of Device: PATCH, PLEDGET, INTRACARDIAC
• Manufacturer (Section D): CORMATRIX CARDIOVASCULAR, INC.; 1100 old ellis rd; roswell GA 30076
• MDR Report Key: 3676512
• MDR Text Key: 20109217
• Report Number: 3676512
• Device Sequence Number: 1
• Product Code: DXZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: CMCV-003-402
• Device Lot Number: M12K1098
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2014
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR