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

Model Number	ONXM-27/29
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
Event or Problem 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.
Additional 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
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): CRYOLIFE, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 5974825
• Report Number: 1649833-2016-00057
• Device Sequence Number: 98329
• Product Code: LWQ
• UDI-Device Identifier: 00851788001280
• UDI-Public: 00851788001280
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2016

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
• Operator of Device: 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
• Distributor Facility Aware Date: 08/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2016
• Supplement Report FDA Received Date: 11/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other