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 Deformation (2976)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/20/2019
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 6/19/18 having met all internal qc acceptance requirements.There were no non-conformance's 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-conformance's.It was stated that, "based upon the review results, the non-conformance had no impact on the reported issue".The ifu instructions for the vascular product that was provided with the product (part number art-20713a) was reviewed and based on the information provided by the site, the ecm patch was prepared according to instructions for use.Under the section warnings and precautions, it states: "device is not recommended to be used with platelet gel." pseudoaneurysm /aneurysm is listed as a potential complication.Additional information will be submitted once investigation is completed.
Event or Problem Description
It was reported that a vascular ecm (fp-20437-09, cmcv-014-609, 1cm x 10cm) was implanted for a carotid endarterectomy (cea) on (b)(6) 2018 in a male patient.The device was soaked for 30 seconds in saline.Standard procedure guidelines were followed.The ecm was sutured to patient tissue with a prolene suture.No adhesive agents were used; may have used thrombin.Symptoms occurred around 3-month checkup.Noticeable bulge at wound site.Ultrasound confirmed carotid aneurysm.Pictures during excision on (b)(6) 2019 show large, ballooned aneurysm in the patch.The ecm patch aneurysm was completely excised and replaced with an autologous vein patch.The site states that the event is possibly related to the procedure and probably related to the device.Patient is reported as doing well.
Additional Manufacturer Narrative
Histology diagnosis on (b)(6) 2019 states: chronic active inflammation of graft tissue and surrounding soft tissue, remnants of multilaminate ecm device, extensive luminal thrombosis.

• 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: 8551247
• Report Number: 3005619880-2019-00004
• Device Sequence Number: 2431538
• Product Code: DXZ
• UDI-Device Identifier: 10859389005147
• UDI-Public: 10859389005147
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

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: 08/31/2019
• Device Model Number: CMCV-014-609
• Device Lot Number: M18F1152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 09/11/2019
• 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