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

Model Number ONXMC-25/33

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

Patient Problem No Information (3190)

Event Date 10/18/2018

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 an email on (b)(6) 2018: "while entering [serial number from product] the system alerted me to another valve for this patient [same product different serial number] implanted in (b)(6) 2018.(note an aortic [valve] was implanted in (b)(6) 2018)." a phone call was made to the facility on (b)(6) 2018 to inquire if any valve deficiency has been noted with the product as it was explanted on (b)(6) 2018.The working staff stated, "i do not remember if any deficiency was with the valve as the patient has many problems.I will work on getting clarification." a follow-up phone call was made to [the surgeon] on (b)(6) 2018.The working staff said that the doctor was not available.They did state: "issues are noted in the mitral region; however, when the valve was removed no issues were noted with the valve itself.The old valve was replaced with the same type of valve for this reason." when asked for current patient status and the operative notes, the nurse replied, "i'm sorry but i cannot give you that information.".

Event Description

According to an email on 11/14/2018: "while entering [serial number from product] the system alerted me to another valve for this patient [same product different serial number] implanted in july 2018.(note an aortic [valve] was implanted in may 2018)." a phone call was made to the facility on 11/16/2018 to inquire if any valve deficiency has been noted with the product as it was explanted on (b)(6) 2018.The working staff stated, "i do not remember if any deficiency was with the valve as the patient has many problems.I will work on getting clarification." a follow-up phone call was made to [the surgeon] on 11/19/2018.The working staff said that the doctor was not available.They did state: "issues are noted in the mitral region; however, when the valve was removed no issues were noted with the valve itself.The old valve was replaced with the same type of valve for this reason." when asked for current patient status and the operative notes, the nurse replied, "i'm sorry but i cannot give you that information.".

Manufacturer Narrative

A definitive root cause for the valve explant is unknown.It is likely based on surgical history (prior valve replacement two months beforehand) that patient cardiac comorbidities predisposed conditions requiring additional intervention.Additionally, the hospital noted that, "no issues were noted with the valve itself." nevertheless, the instructions for use (ifu) lists explant as a potential complication following valve replacement.Explant is a known potential complication following valve replacement surgery, but the necessitating cause is unknown.The hospital noted that, "no issues were noted with the valve itself." the device itself met all specifications prior to release without any non-conformances to note.A definitive root cause is unknown.The risk management file thoroughly identifies the process and product hazards for approved indications.Each individual hazard is mitigated and reduced as low as possible by design and process.Post production residual risk is communicated in the product's labeling and ifu.No action necessary.This event does not identify additional hazards or modify the probability and severity of existing hazards.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

• Brand Name: ONX MITRAL PROSTHETIC HEART VALVE
• 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: 8152884
• MDR Text Key: 130074909
• Report Number: 1649833-2018-00175
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2024
• Device Model Number: ONXMC-25/33
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/14/2018
• Date Manufacturer Received: 11/14/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other