MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ AUSTIN ONX MITRAL STANDARD 25; HEART-VALVE, MECHANICAL

Model Number ONXM-25

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Code Available (3191)

Event Date 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to initial reports, upon seating the valve, the leaflet was not functioning optimally.The surgeon tried rotating the valve with great difficulty, however the valve was, ultimately not used.

Manufacturer Narrative

According to initial reports, the valve leaflet was not functioning optimally.The surgeon tried rotating the valve with great difficulty, however the valve was not used.Additional information was received.The surgeon said he implanted the valve anti-anatomically as per company recommendations.The manufacturing records for the onxm-25 sn (b)(6) 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.An evaluation of the returned product was performed.The methods of observation performed were visual, microscopy, physical test.Prior to decontamination, visual examination of valve showed no obvious signs of damage.Both leaflets were freely moving.After decontamination, inspection of the part under the microscope showed no damage to the valve or leaflets.The sewing cuff shows evidence of use where sutures were possibly placed.The part was tested using a size 25 rotator.The rotator was easily able to rotate the part both clockwise and counter-clockwise with no resistance.The issue reported could not be replicated.The leaflets appear to be functioning as intended and the valve rotates freely.Root cause for this event is unknown.No additional actions are required.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 STANDARD 25
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): CRYOLIFE, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 9321554
• MDR Text Key: 180642276
• Report Number: 1649833-2019-00073
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ONXM-25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Distributor Facility Aware Date: 10/29/2019
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 10/29/2019
• Supplement Dates FDA Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other