MAUDE Adverse Event Report: CRYOLIFE, INC. - AUSTIN ONX MITRAL CONFORM 25/33; HEART-VALVE MECHANICAL

Model Number ONXMC-25/33

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 11/15/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

After the surgeon closed the patient he found the leaflet wasn't opening and closing correctly.He went back in and removed valve and replaced it with another onxmc-25/33 valve.That valve worked fine.

Manufacturer Narrative

Note: outcomes attributed to adverse events.Changed to reflect adverse effect not product malfunction.Additional information from the rep indicated the following, ¿the patient was removed from bypass.The surgeon noticed the onxmc-25/33 valve leaflet was not working.The patient was opened up and the surgeon found that native tissue was impinging the prosthetic valve.The surgeon removed that valve and replaced it with the same size on-x valve.¿ the manufacturing records for the onxmc-25/33 sn (b)(4) were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.During the investigation no non-conformances or deviations were noted.The surgeon reported improper leaflet motion, reopened patient and observed leaflet obstruction due to native tissue impingement.The valve was explanted and replaced by a same size on-x valve.Restriction of leaflet motion due to native tissue impingement during surgery makes this a valve positioning issue that was identified by the surgeon and corrected upon replacement with another on-x valve of the same size.The instructions for use (ifu) specifically caution: "when seating the valve, ensure that no suture material or anatomic structures interfere with leaflet motion.The valve's rotation capability may be helpful in avoiding abnormal residual pathology that could interfere with leaflet motion." based on limited available information regarding "leaflet impingement" that, in-vivo would result in excessive leakage resulting in high regurgitation, there is insufficient information to determine a definitive cause of failure.This event does not identify additional hazards or modify the probability and severity of existing hazards.

Event Description

After the surgeon closed the patient he found the leaflet wasn't opening and closing correctly.He went back in and removed valve and replaced it with another onxmc-25/33 valve.That valve worked fine.

• Brand Name: ONX MITRAL CONFORM 25/33
• Type of Device: HEART-VALVE MECHANICAL
• Manufacturer (Section D): CRYOLIFE, INC. - AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd; kennesaw, GA 30144
• MDR Report Key: 6181700
• MDR Text Key: 62599656
• Report Number: 1649833-2016-00081
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2017

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?: Yes
• Device Operator: Physician
• Device Model Number: ONXMC-25/33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/16/2016
• Initial Date Manufacturer Received: 11/16/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention