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

Model Number	CMCV-009-MED
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	05/30/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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".

• Brand Name: CORMATRIX CANGAROO ECM ENVELOPE
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• MDR Report Key: 7045086
• Report Number: 3005619880-2017-00034
• Device Sequence Number: 1851875
• Product Code: FTM
• UDI-Device Identifier: 00859389005034
• UDI-Public: 00859389005034
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K140306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 01/13/2020
• Device Model Number: CMCV-009-MED
• Device Lot Number: M17A1005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1