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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 Hematoma (1884)
Event Date 03/21/2017
Event Type  Injury  
Manufacturer Narrative
The site investigator states that the event is probably related to the procedure and probably related to ecm device. The site investigator reports that the likely cause of the event is related to the patient's "sick sinus syndrome/hematoma". A review of manufacturing records for the reported lot was conducted. The lot was released to distribution on 1/19/2017 having met all quality requirements for workmanship, pyrogen and sterility testing. The cangaroo ecm envelope instructions for use (p/n lb-20266) currently lists 'hematoma' under the potential complications section.
 
Event Description
It was reported that a cangaroo ecm envelope (cmcv-009-med lot# m16n1319) was used on a (b)(6) male with risk factors for infection of diabetes, congestive heart failure and malignancy. A pacemaker was implanted on (b)(6) 2017 with a cangaroo device. The ecm envelope was hydrated with vancomycin and gentamycin. No issues were reported during the initial procedure. At wound check on (b)(6) 2017 the physician identified a hematoma, approximately 3x3cm and stated that subject would have pocket revision performed on (b)(6) 2017. Cormatrix pouch was removed during pocket revision. The site investigator states that the event is probably related to the procedure and probably related to ecm device.
 
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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
MDR Report Key6531111
MDR Text Key73979623
Report Number3005619880-2017-00013
Device Sequence Number1
Product Code FTM
UDI-Device Identifier00859389005034
UDI-Public00859389005034
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 04/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/12/2019
Device Model NumberCMCV-009-MED
Device Lot NumberM16N1319
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 Received03/31/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/19/2017
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: 04/28/2017 Patient Sequence Number: 1
Treatment
BOSTON SCIENTIFIC DUAL CHAMBER PACEMAKER
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