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

Device Problem Insufficient Information (3190)

Patient Problem Pseudoaneurysm (2605)

Event Date 07/11/2017

Event Type  Injury  

Manufacturer Narrative

The cormatrix ecm for carotid repair product was not returned to aziyo for investigation; and further clarification as to specific model number or manufacturer's lot number were not provided despite multiple attempts as documented.No additional information is available.The cause of the reported pseudoaneurysm cannot be conclusively determined.The instructions for use (provided with device, assumed to be 20463-062014 (model number was not provided)) for the cormatrix ecm for carotid repair currently lists pseudoaneurysm as potential complications associated with the procedure and device.

Event Description

It was reported that a (b)(6) had a left carotid artery repair using a 6-0 prolene suture on (b)(6) 2017.The ecm (model and lot number unknown) was soaked in saline for 2 minutes.Nine (9) days post operatively, the patient was at home.He felt a pop in his neck and his neck began to swell.He presented to the office on (b)(6) 2017 and had a large pulsatile mass in his neck.He was admitted with ct scan confirming the diagnosis of a large pseudoaneurysm.Patient was transferred to (b)(6) and underwent re-exploration and explantation with repair of the carotid with another patch.The explanted device is not available for evaluation.Exact date of explant is unknown.Final outcome of the patient is that the patient is neurologically intact.He does have hoarseness of his voice after the re-exploration.The attending physician believes the event was related to the device.Additional information has been requested multiple times with no response to date.If/when additional information is received, a supplement will be filed.

• Brand Name: CORMATRIX ECM FOR CAROTID 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: 7109951
• MDR Text Key: 94635261
• Report Number: 3005619880-2017-00036
• Device Sequence Number: 1
• Product Code: DXZ
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 73 YR
• Patient Weight: 83