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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORMATRIX CARDIOVASCULAR, INC. CORMATRIX CANGAROO ECM ENVELOPE MESH, SURGICAL

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CORMATRIX CARDIOVASCULAR, INC. CORMATRIX CANGAROO ECM ENVELOPE MESH, SURGICAL Back to Search Results
Model Number CMCV-009-MED
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cellulitis (1768)
Event Date 10/28/2016
Event Type  Injury  
Manufacturer Narrative
The site investigator states that the probable cause of the event is unknown, and is possibly related to the procedure and possibly related to the ecm device. However, cellulitis is a bacterial infection, typically streptococcus or staphylococcus, that enters through a disruption in the skin, such as in surgical procedures. It cannot be conclusively determined that the cangaroo ecm envelope was involved in this event. Also, blood cultures taken during hospital admission were negative and the event was resolved by the two week post-operative visit. The cangaroo device remains implanted with no further incidents reported. Manufacturing review of the device history record for the reported lot shows that all units were quality released on 9/9/2016 having met all internal qc acceptance requirements for workmanship as well as biological indicator testing for product sterility. The instructions for use of the cormatrix cangaroo ecm envelope ((b)(4)) currently lists the risk of infection as a potential complication.
 
Event Description
It was reported that a cangaroo ecm envelope (cmcv-009-med lot# m16k1231) was used on a (b)(6) year old white female with risk factors for infection of systemic anticoagulants and congestive heart failure. Unknown if received a pre-treatment antibiotic. A pacemaker change-out/upgrade was performed on (b)(6) 2016 using the cangaroo device that had been hydrated in bacitracin antibiotic solution. On (b)(6) 2016 the patient developed probable cellulitis and skin infection around the pacemaker site and was treated in the emergency room and then was admitted to the hospital for further observation and treatment. The cellulitis was treated with iv vancomycin and oral clindaymycin. The patient was discharged on (b)(6) 2016 and directed to follow up with cardiologist in 5 days. Follow up with cardiologist showed no evidence of infection at the (b)(6) 2016 visit.
 
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Brand NameCORMATRIX CANGAROO ECM ENVELOPE
Type of DeviceMESH, SURGICAL
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
4705144019
MDR Report Key6378624
MDR Text Key69095619
Report Number3005619880-2017-00008
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140306
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/11/2018
Device Model NumberCMCV-009-MED
Device Lot NumberM16K1231
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/03/2017 Patient Sequence Number: 1
Treatment
PACEMAKER
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