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

Model Number CMCV-014-609

Device Problem Delamination (2904)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2017

Event Type  malfunction  

Manufacturer Narrative

The sample that was returned and used by the facility was observed to have been separated on one end of the 1 cm x 10 cm strip that had been trimmed during the procedure to form a point.Approximately 1 cm on each long side of the ecm strip was trimmed into a triangular shape, and it appeared to be one layer of ecm had separated on the approximately 4 cm deep into the sample.No other areas of separation were observed.Hydration times of the returned sample as well as handling of the ecm prior to attempting implant is unknown.Therefore, the exact root cause cannot be conclusively determined.A lot sample of the same manufacturing lot provided by the customer was evaluated per ifu steps using the maximum hydration soak of 2 minutes, the issue of delamination/separation of layers was not able to be confirmed.No delamination was able to be reproduced in the lot sample provided when used per the ifu.Quality review of the of the device history record for the reported lot shows that all units were quality released having met all internal manufacturing specifications and qc acceptance requirements for workmanship and biological testing for product sterility.

Event Description

It was reported that on (b)(6) 2017 the physician was placing the cormatrix ecm for vascular repair product over the defect and started sewing it in place.While suturing in place, the physician noticed that the product layers had started separating.Physician stopped, removed the product and replaced it with a different brand product.The model and lot number used are cmcv-014-609/ m16f1149.No additional information has been provided at this time.

• Brand Name: CORMATRIX ECM FOR VASCULAR REPAIR
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC
• Manufacturer (Section D): CORMATRIX CARDIOVASCULAR, INC.; 1100 old ellis road; roswell GA 30076
• Manufacturer (Section G): CORMATRIX CARDIOVASCULAR, INC.; 1100 old ellis road; roswell GA 30076
• Manufacturer Contact: andrew green ; 1100 old ellis road; roswell, GA 30076 ; 6785662628
• MDR Report Key: 6609836
• MDR Text Key: 76628078
• Report Number: 3005619880-2017-00019
• Device Sequence Number: 1
• Product Code: DXZ
• UDI-Device Identifier: 10859389005147
• UDI-Public: 10859389005147
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2017
• Device Model Number: CMCV-014-609
• Device Lot Number: M16F1149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention