MAUDE Adverse Event Report: AZIYO BIOLOGICS, INC. CORMATRIX ECM FOR PERICARDIAL CLOSURE; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Model Number	CMCV-060-402
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	06/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the complaint log shows that there were no other complaints associated with this lot number.Manufacturing review of the device history record for the reported lot shows that all units were quality released on 11/10/2016 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.The cause of the reported dehiscence cannot be conclusively determined as the device was not returned for evaluation and was utilized in an off-label manner for an atrial septal defect (asd) which led to a dehiscence.The instructions for use (20461-062014 provided with device) for the cormatrix ecm for pericardial closure states under indications for use: "the cormatrix ecm for pericardial closure is intended for the reconstruction of the pericardium".
Event or Problem Description
The ecm was soaked for 'min' and was sutured to tension with 4-0 prolene suture.No delamination was observed.No glue, platelet gel, or hemostatic agents were used.Ecm was not attached to a homograft or synthetic device.Two (2) months after implantation patch failed/dehisced.A reoperation with autologous pericardium was completed (explant date not provided).Sample is not available for evaluation.Final patient outcome: doing well.The surgeon believes the event was related to the device and states "most likely, but impossible to prove".Additional attempts to gather information were requested of the site on 11/9/2017 and 11/15/2017 with no success.

• Brand Name: CORMATRIX ECM FOR PERICARDIAL CLOSURE
• Common Device Name: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• MDR Report Key: 7096416
• Report Number: 3005619880-2017-00035
• Device Sequence Number: 1182425
• Product Code: DXZ
• UDI-Device Identifier: 10859389005017
• UDI-Public: 10859389005017
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051405
• 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): 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 01/31/2018
• Device Model Number: CMCV-060-402
• Device Lot Number: M16M1286
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR