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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Reaction (2414)
Date of Event	11/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cormatrix ecm for pericardial closure product was not returned to aziyo for investigation.Manufacturing review of the device history record for the reported lot shows that all units were quality released having met all internal qc acceptance requirements.There were no non-conformances associated with the manufacturing lot during production and final packaging.Oem supplier reviewed the sub-lots associated with the reported lot and provided specific disposition details of non-conformances.Oem supplier stated that, "based upon the review results, the non-conformances had no impact on the reported issue." the ifu instructions for the pericardial closure product that was provided with the product (part number 20461) under the section labeled "potential complications" - allergic reaction and infection are listed.Per conversation with facility, the physician likes to use more than one ecm product "for just more pericardium coverage".Since the facility stated that two products were used on the patient, it is unknown at this time how the ecm's were sutured in place or possibly to each other.It is also unknown if the products were stacked on top of each other or their position in relation to the defect.Therefore, two reports to the fda were filed to capture data from both ecm products (reference this report and 3005619880-2018-00007).The exact cause of the reported event cannot be conclusively determined.Multiple attempts to gather additional information from the facility were unsuccessful.Should additional information become available, this report will be updated accordingly.
Event or Problem Description
A mitral valve replacement was completed on a (b)(6) male on (b)(6) 2017 with use of ecm patches that was soaked in saline (soak time unknown).It was reported that the patient developed a cough approximately a week after the procedure.In (b)(6) 2017 (specific date unknown) a thoracentesis was completed and fluid was removed from chest area.On (b)(6) 2017 a chamberlain procedure was completed and it was reported that approximately 2/3 of the patch was removed (specific details are unknown).It was reported that the pocket of fluid was not a hematoma but rather turbid fluid with no infection present (based from hospital pathology).

• 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: 7562042
• Report Number: 3005619880-2018-00006
• Device Sequence Number: 177412
• Product Code: DXZ
• UDI-Device Identifier: 00859389005010
• UDI-Public: 00859389005010
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K051405
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/31/2018

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: 05/31/2018
• Device Model Number: CMCV-060-402
• Device Lot Number: M17B1034
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 06/01/2018
• 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: 53 YR