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

Model Number CMCV-013-609

Device Problem Material Distortion (2977)

Patient Problem Aneurysm (1708)

Event Date 04/10/2018

Event Type  Injury  

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 (b)(6) 2017 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.It was stated that, "based upon the review results, the non-conformances had no impact on the reported issue." the ifu provided with the product (part number 20438-302514) was reviewed and based on the information provided by the site, the ecm patch was prepared according to the instructions for use.The exact cause of the reported event cannot be conclusively determined.Reports of aneurysm are within expected occurrence ratings identified in the risk management files.Based on the low frequency of occurrence and inconclusive root cause, no further corrective action is required at this time.

Event Description

It was reported that the patient, a (b)(6) male, underwent a right carotid endarterectomy at a cardiovascular facility on (b)(6) 2017.The ecm patch was soaked in a saline solution for 1-2 minutes exactly.A 2-4 week follow up was completed and no complications were observed.At a later date (specific date unknown) the patient had an ultrasound/duplex study completed when he was going to have a colonoscopy with another physician.It was noted at that time that there was an aneurysm present at the site of ecm patch implant and the patient was referred back to the original cardiovascular facility.A ct angiogram was performed on (b)(6) 2018 and it was confirmed that the patient had an aneurysm at the site of the implanted ecm patch device and the size was approximately 3cm x 2cm x 2cm circular.Corrective surgery was performed on (b)(6) 2018.The ecm patch was opened up and the site was cleaned, however it can be noted that the original ecm patch was not fully explanted and only a small part (specific size unknown) of the cormatrix ecm patch was sent to hospital pathology and it was confirmed the area was a true aneurysm (no rupture/leak - all encapsulated).Another patch (bovine pericardial) was used for the corrective surgery.Exact pathology details are not available.It can be noted that the facility reported the event to the fda on approximately (b)(6) 2018 through hospital's general counsel.Dr.Kim (original implanting physician) does not have an internal reference number or a reference number from the fda.The physician does not believe the event is related to the procedure and is probably related to the device.In the opinion of the implanting/treating physician, the probable cause was stated as, "ecm patch not thick enough for vascular pressure.".

• Brand Name: CORMATRIX ECM FOR VASCULAR REPAIR
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• Manufacturer (Section G): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• Manufacturer Contact: andrew green ; 1100 old ellis road; ste 1200; roswell, GA 30076
• MDR Report Key: 7481148
• MDR Text Key: 107170213
• Report Number: 3005619880-2018-00005
• Device Sequence Number: 1
• Product Code: DXZ
• UDI-Device Identifier: 00859389005140
• UDI-Public: 00859389005140
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2018
• Device Model Number: CMCV-013-609
• Device Lot Number: M17E1101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR