MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL STANDARD 27/29; HEART VALVE MECHANICAL

Model Number ONXM-27/29

Device Problem Incomplete Coaptation (2507)

Patient Problem Dyspnea (1816)

Event Date 11/08/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A (b)(6) female with rheumatic heart disease with severe mitral stenosis received a valve replacement surgery (b)(6) 2017 with on-x mitral heart valve onxm-27/29, serial number unknown.On (b)(6) 2017 the patient presented with dyspnea for 2-3 days.An echo revealed a leaflet was stuck in the closing position with gradients max of pg=40.29mmhg an mean pg=29/65jg across mv.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

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.During the investigation no non-conformances or deviations were noted.A sample evaluation was performed for the onxm-27/29 sn (b)(4) by visual examination.The following was observed; the valve was received and a visual inspection after decontamination found no evidence of thrombosis.The valve was disassembled and evaluated for dimensional, visual, and functional requirements.Valve components and sub-assembly passed specification requirements.The sample evaluation does not find any noted deficiencies of the valve.A review was performed of the available information.The onxm-27/29 of previously unknown serial number later identified as sn (b)(4) was reported as implanted (b)(6) 2017 in the mitral position of a (b)(6) female.An echocardiogram performed five days post-op indicated a normally functioning mechanical mitral valve, but a second echo on (b)(6) 2017 (49 days postop) indicated a stuck leaflet in the bileaflet device resulting in a high pressure gradient across the valve (peak 40mmhg , mean 30mmhg).Correspondence from the institution makes no mention of the cause of the leaflet immobility, but the field report proposes a suspected thrombosed valve and planned explantation.The valve was later explanted and returned to the manufacturer for examination.Except for the immobility of a leaflet described on echo, we have no other clinical evidence identifying a root cause.Concerning the possibility of thrombosis, we have no record of anticoagulation so we don't know if the patient was compliant with the recommendations or if difficulties presented regarding clinical management of inr.However, the explanted valve, as received by the manufacturer, did not show any evidence of thrombus and met all dimensional, visual, and functional requirements.Consequently, the echo stands alone as evidence of any leaflet immobility, and the diagnosis of thrombus is not supported by any other.Consequently there is not enough objective information to establish what, if any, relationship the reported leaflet immobility has to do with the valve performance.While thrombosis is a recognized potential complication associated with prosthetic mitral valve replacement [instructions for use], its occurrence is relatively rare.Objective performance criteria report an historical thrombosis incidence of 0.8% per valve-year for all rigid prosthetic valves (iso 5840:2005].The on-x heart valve design fmea 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.Based on the available information, root cause for this event is unknown.No further action is warranted at this time.

Event Description

A (b)(6) female with rheumatic heart disease with severe mitral stenosis received a valve replacement surgery 09/20/2017 with on-x mitral heart valve onxm-27/29, serial number unknown.On (b)(6) 2017 the patient presented with dyspnea for 2-3 days.An echo revealed a leaflet was stuck in the closing position with gradients max of pg=40.29mmhg an mean pg=29/65jg across mv.

• Brand Name: ONX MITRAL STANDARD 27/29
• Type of Device: HEART VALVE MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 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: 7082721
• MDR Text Key: 93737725
• Report Number: 1649833-2017-00088
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXM-27/29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/11/2017
• Date Manufacturer Received: 11/11/2017
• 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): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 21 YR