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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-LRG
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Unspecified Infection (1930)
Event Date 11/10/2016
Event Type  Injury  
Manufacturer Narrative
Manufacturing review of the device history record for the reported lot shows that all units were quality released on 09/13/2016 having met all internal manufacturing specifications and qc acceptance requirements for workmanship and biological indicator testing for product sterility. The instructions for use for the cormatrix cangaroo ecm envelope ((b)(4)) currently lists the risks of infection and hematoma as potential complications. The site investigator indicates that in their opinion, the probable cause of the event is related to the patient's history of blood thinner usage. The device remains implanted and no further incidents/events have been reported.
 
Event Description
It was reported that a cangaroo ecm envelope (model # cmcv-009-lrg lot# m16k1239) was hydrated in a 1 gram vancomycin/1000 milliliter normal saline solution and implanted into a (b)(6) male patient with a history of smoking and congestive heart failure. The upgrade/change-out procedure used a bi-ventricular defibrillator and was performed on (b)(6) 2016 with no issues during procedure. On (b)(6) 2016 patient was admitted to hospital for small soft hematoma with slight odor and old dark blood. The reported event resolved without intervention, possible cellulitis to pocket that was resolved on (b)(6) 2016 with intravenous vancomycin without sequellae. At the 4 - 6 week follow-up visit no issues were reported. Site investigator reports that the intensity of event was moderate, and the relationship of the event to the procedure and device were probably related. In the opinion of the investigator, the event was probably caused from the history of blood thinner usage. The device remains implanted with no further incident/events reported.
 
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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 Key6333235
MDR Text Key67534343
Report Number3005619880-2017-00006
Device Sequence Number1
Product Code FTM
UDI-Device Identifier00859389005065
UDI-Public00859389005065
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 02/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/01/2018
Device Model NumberCMCV-009-LRG
Device Lot NumberM16K1239
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 Received12/12/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/13/2016
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: 02/15/2017 Patient Sequence Number: 1
Treatment
BI-VENTRICULAR DEFIBRILLATOR
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