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

Model Number CMCV-009-XLG

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 07/25/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturing review of the device history record for the reported lot shows that all units were quality released on 9/27/2016 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 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.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) year old male who had an initial procedure of icd replaced with a cardiac resynchronization therapy defibrillator (crt-d) on (b)(6) 2017 where the ecm (cmcv-009-xlg, lot # m16h1214) was hydrated in normal saline (unknown length of time).At the subjects incision check on (b)(6) 2017, a moderate hematoma was noted at the incision site.At the 4-6 week visit on (b)(6) 2017 the hematoma was resolved.This required no intervention.The site investigator states that the event is possibly related to the procedure and possibly related to the device.The probable cause is listed as "procedure".

• Brand Name: CORMATRIX CANGAROO ECM ENVELOPE
• Type of Device: MESH, 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 Key: 6937268
• MDR Text Key: 89149622
• Report Number: 3005619880-2017-00029
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00859389005072
• UDI-Public: 00859389005072
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/24/2019
• Device Model Number: CMCV-009-XLG
• Device Lot Number: M16H1214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR