MAUDE Adverse Event Report: AZIYO BIOLOGICS CORMATRIX CARDIOVASCULAR; VASCULAR PATCH

Model Number CMCV-013-609

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Aneurysm (1708)

Event Date 10/26/2017

Event Type  Injury  

Event Description

Aneurysm arising from site of patch placed on (b)(6) 2017.Repaired with bovine pericardial patch.Diagnosis or reason for use: carotid stenosis.

• Brand Name: CORMATRIX CARDIOVASCULAR
• Type of Device: VASCULAR PATCH
• Manufacturer (Section D): AZIYO BIOLOGICS
• MDR Report Key: 7453673
• MDR Text Key: 106453327
• Report Number: MW5076646
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CMCV-013-609
• Device Lot Number: M17E110J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR