MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X MECHANICAL VALVE; HEART VALVE MECHANICAL

Model Number ONXM31/33

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Death (1802); High Blood Pressure/ Hypertension (1908); Cardiogenic Shock (2262); Multiple Organ Failure (3261)

Event Date 01/14/2020

Event Type  Death  

Event Description

Dislodged leaflet from mitral valve from mechanical mitral valve prosthesis resulting in cardiogenic shock and metabolic acidosis.Attempted mitral valve replacement, unsuccessful.Pt developed prolonged hypertension and hypo perfusion, developed multi organ failure and expired.Fda safety report id# (b)(4).

• Brand Name: ON-X MECHANICAL VALVE
• Type of Device: HEART VALVE MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC. ; austin TX
• MDR Report Key: 9610497
• MDR Text Key: 175842079
• Report Number: MW5092348
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ONXM31/33
• Device Catalogue Number: OMXM31/33
• Device Lot Number: 6629714
• Was Device Available for Evaluation?: 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): Death
• Patient Age: 50 YR
• Patient Weight: 70