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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-XLG
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cellulitis (1768)
Event Date 09/04/2016
Event Type  Injury  
Manufacturer Narrative
Per information received from the site, they reported: "patient presented to hospital for fever and pain over his icd implant and was diagnosed with suspected cellulitis; normal white cell count. " the event is stated as possibly being related to the procedure. The event is not related to the device.
 
Manufacturer Narrative
Preceding the onset of the identified cellulitis, patient states that he was changing a tire two days prior to onset of soreness, fever, chills and redness which resulted in his visit to the er. Manufacturing records for referenced lot were reviewed and that all conditions for manufacturing acceptance were satisfactorily met including product sterility testing and the lot was released to distribution having met all release requirements. The instruction for use for the cangaro ecm envelope lists infection as a potential complication.
 
Event Description
It was reported that a cormatrix cangaroo ecm envelope (cmcv-009-xlg, lot #m16b1058) was hydrated with ancef and utilized in an implantable cardioverter defibrillator (icd) procedure performed on (b)(6) 2016 on a (b)(6) yr. Old male patient with risk factors for infection including obesity, congestive heart failure, and cardiomyopathy. Patient was given pre-treatment antibiotics. At wound check visit ((b)(6) 2016) no issues were noted, and there was no 4 - 6 week follow-up visit conducted. At 3 month follow-up ((b)(6) 2016), it was noted that patient had experienced a minor cied infection. The infection was noted to have begun on (b)(6) 2016 when patient presented to emergency department with fever and pain over the icd site. Computed tomography (ct) performed for abcess, but was negative and wound was cultured for infection and showed no growth. Patient diagnosed with left chest wall cellulitis, without fluid and received intravenous vancomycin. The site investigator reports that the event is possibly related to the procedure and possibly related to the device.
 
Manufacturer Narrative
Cormatrix had conversation with study coordinator at the hospital site on 3/20/2017 in which it was determined that following the patient exiting the post-market study on (b)(6) 2016, the patient returned to the emergency department for pain, swelling and fever at the site of the device. The device was subsequently explanted on (b)(6) 2016. Based upon the information received on 2/27/2017, the site investigator states that the probable cause of the event was related to the patient's history of intravenous (iv) drug use. No further information is available at this time, should additional information become available a supplemental report will be filed.
 
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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 Key6415407
MDR Text Key112487929
Report Number3005619880-2017-00011
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,Followup,Followup
Report Date 12/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/23/2016
Device Model NumberCMCV-009-XLG
Device Lot NumberM16B1058
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 Received02/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/17/2016
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: 03/17/2017 Patient Sequence Number: 1
Treatment
ST. JUDE ICD
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