MAUDE Adverse Event Report: CORMATRIX CARDIOVASCULAR, INC. CORMATRIX ECM FOR CARDIAC TISSUE REPAIR; PATCH, PLEDGET AND INTRACARDIAC

Model Number	CMCV-004-404
Medical Device Problem Codes	Delamination (2904); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample has not been received for evaluation.A supplemental report will be submitted if additional relevant case information or the sample is received.
Event or Problem Description
It was reported on july 19, 2016 that the cormatrix ecm for cardiac tissue repair 4cm x 7cm (cmcv-004-404, lot#m16b1041) was going to be used as a main pulmonary artery patch.When packaging was opened, the ecm material (dry) was "thicker than normal and felt cushiony, like a mattress".Ecm material was then hydrated and at the time of use material started to delaminate almost immediately.Additional information received on july 26, 2016 states that the doctor did implant the ecm material after cutting out the portion that appeared to have delaminated.As of today, there is no additional information.If and when additional information is received, the file will be updated accordingly.A review of the dhr and sublots shows that there were no contributing issues to the reported event.

• Brand Name: CORMATRIX ECM FOR CARDIAC TISSUE REPAIR
• Common Device Name: PATCH, PLEDGET AND INTRACARDIAC
• Manufacturer (Section D): CORMATRIX CARDIOVASCULAR, INC.; 1100 old ellis road; roswell GA 30076
• MDR Report Key: 5881839
• Report Number: 3005619880-2016-00021
• Device Sequence Number: 1326333
• Product Code: DXZ
• UDI-Device Identifier: 10859389005055
• UDI-Public: 10859389005055
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K063349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2016

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
• Operator of Device: Physician
• Device Expiration Date: 05/31/2017
• Device Model Number: CMCV-004-404
• Device Lot Number: M16B1041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2016
• Initial Report FDA Received Date: 08/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention