MAUDE Adverse Event Report: AZIYO BIOLOGICS, INC. PROXICOR FOR PERICARDIAL CLOSURE; PATCH, PLEDGET AND INTRACARDIAC, PETP - DXZ

Model Number	CMCV-003-402
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	05/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review of the device history record for the reported lot shows that all units were quality released for distribution on 05/23/2019 having met all internal qc acceptance requirements.There were no non-conformances associated with the manufacturing lot during final packaging.As the reported event of tamponade is typically associated with placement/suturing of the proxicor for pericardial closure device, a request for subassembly manufacturing lot review from our ecm component supplier was not made as there were no allegations of device failure.It can be noted that it appears from the reported information that the proxicor device was prepared (e.G.Hydrated) per the instructions for use, including no use of hemostatic or adhesive agents.Following device removal, patient was reported as recovering.It can be noted that per the proxicor for pericardial closure instruction for use (art-20707a) provided with the packaged device, that the potential complication of cardiac tamponade is listed for the procedure and use of the device.Although the exact cause of the reported event cannot be conclusively determined, tamponade is a known complication of pericardial closure.It is not anticipated that any additional information will be forthcoming related to this event.
Event or Problem Description
It was reported on 05/29/2020 that a proxicor for pericardial closure device (model cmcv-003-402 lot# m19e1211) was placed during a procedure performed on (b)(6) 2020 to close the pericardium on a (b)(6) male patient.Once the proxicor was in place, the patient developed symptoms of tamponade.Decrease in blood pressure (bp), increase in cardovascular pressure (cvp) and decreased left ventricular (lv) function.Proxicor was removed.Physician stated that the probable cause of the event was tightness due to the proxicor for pericardial closure device being placed.Patient is recovering following removal.

• Brand Name: PROXICOR FOR PERICARDIAL CLOSURE
• Common Device Name: PATCH, PLEDGET AND INTRACARDIAC, PETP - DXZ
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell, ga
• MDR Report Key: 10202399
• Report Number: 3005619880-2020-00036
• Device Sequence Number: 2297133
• Product Code: DXZ
• UDI-Device Identifier: 10859389005017
• UDI-Public: 10859389005017
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051405
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2020

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: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: CMCV-003-402
• Device Lot Number: M19E1211
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 06/26/2020
• 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: 46 YR