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

Model Number	CMCV-014-609
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	08/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the complaint log shows that this is the only complaint associated with this lot number.Manufacturing review of the device history record for the reported lot shows that all units were quality released on 2/9/2018 having met all internal qc acceptance requirements.There were no non-conformances associated with the manufacturing lot during production and final packaging.The oem supplier reviewed the sub-lots associated with the reported lot and provided specific disposition details of non-conformances.It was stated that, "based upon the review results, the non-conformances had no impact on the reported issue." the instructions for use (ifu) for the vascular product that was provided with the product (part number 20438-032514) was reviewed and it lists stroke as a potential complication.The exact cause of the reported event cannot be conclusively determined.
Event or Problem Description
On 8/6/2018, aziyo received a report of an incident associated with use of ecm for vascular repair (additional details were provided on 8/15/2018).The patient is a (b)(6) female who underwent carotid endarterectomy repair on (b)(6) 2018 using a 1 x 10 cm ecm for vascular repair.On (b)(6) 2018, the patient was brought to the hospital for excessive bleeding at the carotid endarterectomy incision site; it was also reported that the patient suffered a stroke.The patient underwent surgery where a 6 x 12 cm hematoma was drained, and the ecm was reported to be split or ruptured down the middle (not along the suture line).The ecm was removed and a bovine pericardial patch was sutured in.The incision was closed and the patient was admitted.The event was indicated to be probably related to the procedure and probably related to the device.The patient is recovering.

• Brand Name: CORMATRIX ECM FOR VASCULAR REPAIR
• 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: 7843483
• Report Number: 3005619880-2018-00009
• Device Sequence Number: 1155674
• Product Code: DXZ
• UDI-Device Identifier: 10859389005147
• UDI-Public: 10859389005147
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K140789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2018

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: No Information
• Device Expiration Date: 07/31/2019
• Device Model Number: CMCV-014-609
• Device Lot Number: M18B1032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 09/04/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 78 YR