MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ AUSTIN ONX MITRAL STANDARD 27/29; HEART-VALVE, MECHANICAL

Model Number ONXM-27/29

Device Problem Partial Blockage (1065)

Patient Problem No Code Available (3191)

Event Date 08/12/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Dr.(b)(6) of (b)(6) hospital used a m27/29 (sn (b)(4), expiry date: 2020-02-10) to perform a mvr two weeks ago.After finishing the sewing, he used the leaflet probe to test the movement of the leaflets.Dr.(b)(6) said there was one leaflet not moving properly.He used the rotator to turn the valve leaflets to another position, it did not improve the leaflet movement.Dr.(b)(6) finally decided to remove this m 27/29 from patient and replaced by another on-x m 27/29.The mvr was completed without affecting the quality of operation.Dr.(b)(6) complained about the quality of product.

Manufacturer Narrative

A sample review was performed on the on-x mitral heart valve ¿ 27/29 (onxm-27/29, sn (b)(4)) on 10/21/2016 via gross visual examination and dimensional inspection.The valve met all dimension and functional inspections; it is likely that the suspect leaflet was prevented from moving by interference from the subvalvular retained mitral apparatus.  the manufacturing records for the onxm-27/29, 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.  evidence gathered in the sample review concludes that the leaflet impingement was likely due to the physiological interference and is addressed in the ifu.The dfmea addresses excessive leakage under valve mechanics, listing one cause of failure as leaflet impingement.Additionally, the failure mode identified during the sample evaluation is a monitored event assessed in the bi-annual risk assessment for the on-x heart valve.This event does not identify additional hazards or modify the probability and severity of existing hazards.Evaluation of the returned valve indicated that the valve met specifications and concluded that the leaflet impingement was likely due to physiological interference such as subvalvular retained mitral apparatus.Additionally, the surgeon replaced the valve with another on-x valve of the same size, and the second valve did not present with leaflet motion issues.A review of manufacturing records indicates that all lots passed functional testing and met release specifications.

• Brand Name: ONX MITRAL STANDARD 27/29
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): CRYOLIFE, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): CRYOLIFE, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd; kennesaw, GA 30144
• MDR Report Key: 5974825
• MDR Text Key: 55562030
• Report Number: 1649833-2016-00057
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001280
• UDI-Public: 00851788001280
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/10/2020
• Device Model Number: ONXM-27/29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/26/2016
• Date Manufacturer Received: 08/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other