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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 Problems Hematoma (1884); Unspecified Infection (1930)
Event Date 07/07/2016
Event Type  Injury  
Manufacturer Narrative
Per information received from the site, they reported that the doctor does not believe the event was related to the ecm device. The probable cause of the event was listed as, "allergic reaction to foreign body (cied)". The updated form received from the site states the event is not related to the device.
 
Manufacturer Narrative
The site investigator noted that the event is possibly related to the procedure, and probably related to the device, however the exact relationship to the device cannot be conclusively determined as the device was neither returned for evaluation, nor was the pocket or wound swabbed for cultures. Additional questions have been presented to the site and implanting physician and a follow-up report will be submitted if any additional information is received impacting the results or conclusions of this report. The instructions for use for the cangaroo ecm envelope currently lists infection and hematoma as potential complications associated with the procedure and device. A review of manufacturing records for the reported lot has shown that all manufacturing and inspection criteria were met for this lot including product sterility testing supporting the release of this manufacturing lot.
 
Event Description
It was reported that a cangaroo ecm envelope (cmcv-009-med lot #m16d1119) was used during a pacemaker implant procedure performed on (b)(6) 2016 on an (b)(6) male with no reported risk factors for infection. The cangaroo ecm envelope was hydrated in vancomycin, and the patient received iv antibiotics pre-treatment. At the wound check conducted on (b)(6) 2016 a 3 cm hematoma was noted at the implant site with an onset date of (b)(6) 2016 determined by physician. The site looked good with resolution of the hematoma and no signs of infection. On (b)(6) 2016, patient presented to the emergency room with complaints of sepsis, fever of 103 degrees, abdominal pain, and blood in urine. At time of er visit the left upper chest was mildly tender at pacemaker site, patient discharged with diagnosis of acute cystitis (uti) and given oral antibiotic and tylenol for fever. On (b)(6) 2016 pacemaker was explanted and patient admitted for infection by iv antibiotics. Patient was discharged from hospital on (b)(6) 2016 and event had resolved at the next office visit on (b)(6) 2016.
 
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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 Key6416626
MDR Text Key112488013
Report Number3005619880-2017-00010
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,Followup
Report Date 12/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/23/2016
Device Model NumberCMCV-009-MED
Device Lot NumberM16D1119
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 Received02/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/20/2016
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: 03/20/2017 Patient Sequence Number: 1
Treatment
BIOTRONIK PACEMAKER
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