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U.S. Department of Health and Human Services

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

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AZIYO BIOLOGICS, 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 Hematoma (1884)
Event Date 05/30/2017
Event Type  malfunction  
Manufacturer Narrative
The site investigator noted that the event is possibly related to the procedure and possibly related to the device. The probable cause is listed as, "procedure". However the exact relationship to the device cannot be conclusively determined as the device was not returned for evaluation. Manufacturing review of the device history record for the reported lot shows that all units were quality released on 2/15/2017 having met all internal qc acceptance requirements. All sterilization records, and bioburden testing indicate successful sterilization process, and passing lal and product sterility results allowed the lot to be released having met all criteria for manufacturing release. There were no non-conformances associated with the manufacturing lot during production, sterilization and final packaging. The instructions for use (lb-20266 provided with device) for the cangaroo ecm envelope currently lists hematoma as potential complications associated with the procedure and device.
 
Event Description
The subject is a (b)(6) female who had an initial st. Jude medical pacemaker implanted with ecm (cmcv-009-med, lot# m17a1005) on (b)(6) 2017. At the (b)(6) 2017 wound check visit subject had "left pectoral region of chest wound with small firm hematoma and yellow bruising present. " hematoma remained at the 4-6 week visit on (b)(6) 2017 and was resolved at the 3 month follow-up visit on (b)(6) 2017 the event resolved without sequelae with no medical intervention. The site investigator states that the event is possibly related to the procedure and possibly related to the device. The probable cause of the event is listed as, "procedure".
 
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Brand NameCORMATRIX CANGAROO ECM ENVELOPE
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
AZIYO BIOLOGICS, INC.
1100 old ellis road
ste 1200
roswell GA 30076
Manufacturer (Section G)
AZIYO BIOLOGICS, INC.
1100 old ellis road
ste 1200
roswell GA 30076
Manufacturer Contact
andrew green
1100 old ellis road
ste 1200
roswell, GA 30076
MDR Report Key7045086
MDR Text Key93202255
Report Number3005619880-2017-00034
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 11/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/13/2020
Device Model NumberCMCV-009-MED
Device Lot NumberM17A1005
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/15/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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