MAUDE Adverse Event Report: CRYOLIFE, INC. ON-X MECHANICAL VALVE CONDUIT 27/29 MM; HEART-VALVE, MECHANICAL

Model Number ON-X VALVE CONDUIT

Device Problems Product Quality Problem (1506); Device Operates Differently Than Expected (2913)

Patient Problems Stroke/CVA (1770); Embolism (1829)

Event Date 05/25/2018

Event Type  Injury  

Event Description

The pt had a bentall procedure aortic root replacement with 27/29 mm on-x mechanical valve conduit performed on (b)(6) 2015.The device had fda clearance for lower than typical inr levels for anticoagulation with goal inr 1.5-2.0.On (b)(6) 2018, the pt had a cardioembolic stroke with an inr of 1.41.Minimal residual deficits, but the neurology team recommended increasing his inr goal to 2-3.

• Brand Name: ON-X MECHANICAL VALVE CONDUIT 27/29 MM
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): CRYOLIFE, INC. ; kennesaw GA 30144
• MDR Report Key: 7568835
• MDR Text Key: 110204156
• Report Number: MW5077635
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2019
• Device Model Number: ON-X VALVE CONDUIT
• 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): Hospitalization
• Patient Age: 54 YR
• Patient Weight: 118