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

Model Number ONXM UNK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 02/12/2020

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the initial report, "site reported that patient came to the hospital for 4 years follow up visit on (b)(6) 2020.On examination, co-i advised echocardiography and further patient was advised admission.Patient has now been admitted in emergency and conservative management is being done.".

Manufacturer Narrative

Additional information was received.The patient was not implanted with an on-x valve, therefore this event will not be investigated any further.

• Brand Name: ON-X MITRAL VALVE UNKNOWN CONFIGURATION
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 10091652
• MDR Text Key: 192186713
• Report Number: 1649833-2020-00016
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXM UNK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/01/2020
• Initial Date Manufacturer Received: 05/01/2020
• Initial Date FDA Received: 05/27/2020
• Supplement Dates Manufacturer Received: 05/01/2020
• Supplement Dates FDA Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization