MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL STANDARD 25; HEART-VALVE, MECHANICAL

Model Number ONXM-25

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information received, "mitral valve was thought to be compromised due to clot on sewing ring of the valve.Mitral valve was removed and a new valve was implanted."additional information is pending.

Manufacturer Narrative

A review of the returned valve was performed.The results of this evaluation suggest that this valve meets all dimensional and functional inspections.There are no findings that would suggest that the valve contributed to the clot.A review of the available information was performed.The manufacturing records for the onxm-25 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-conformance or deviations were noted.Onxm-25 sn (b)(4) implanted (b)(6) 2010 in the mitral position; explanted and replaced on (b)(6) 2017 (six years, 274 days postop) in the now (b)(4) year old female with a 25mm (b)(6) masters series mechanical valve.Diagnosis was multiple ¿mobile echodensities¿ attached to the sewing ring of the on-x valve- the longest was 1.5cm- as found by echocardiography.The hemodynamic function of the valve was unimpaired (mean gradients of 3-4mmhg) with full movement of the leaflets.A very small pinhole perivalvular leak was also seen.The concern, however, was that an ¿echodensity¿ could detach to become a thromboembolism and lodge in the brain, for instance, causing a stroke.A week on iv [intravenous] heparin anticoagulation resulted in no change to the size of the echodensities and it was felt that simple removal of the material would not eliminate their reappearance, so the proposal was to replace the on-x valve.Medical reports for the implant/explant procedure and associated pre- and post-surgery consultations were made available.The patient was negative for endocarditis (infection).There is no preoperative record of inrs.The patient was discharged to home six days postop.The echodensities were removed at surgery for local pathology analysis and described as layered fibrin.The valve was returned to the manufacturer for analysis.The echodensities, however, were not.At the manufacturer, the valve was cleaned and re-examined for dimensional and functional stability.All measurements met manufacturing specifications.This is a non-obstructive thrombosed valve at risk for thromboembolism and possible subsequent stroke.Clot formation consisted of fibrin threads attached to the sewing cuff of the valve.No clots were observed to be attached to the pyrolyric carbon portion of the valve.The patient¿s compliance with recommended anticoagulation therapy is unknown.There was some speculation among the physicians for patient-prosthesis size mismatch, which is why they chose the st.Jude masters.But the gradients for the (b)(6) postoperatively were the same for as the on-x valve preoperatively (4mmhg), so this is unlikely to be the cause of the patient¿s observed congestive heart failure symptoms of shortness of breath and fatigue (nyha class ii).The observations and diagnoses suggest the root cause is likely to be related to anticoagulation.Besides appropriate dosing, dietary factors could also influence the effectiveness of anticoagulant medication.Without an inr or patient compliance history we cannot definitively ascertain the cause of the fibrin thrombi identified postop.However, inadequate anticoagulation and patient non-compliance are both plausible explanations.The objective performance criteria for thrombosis for all rigid valves is 0.8%/valve year [iso (b)(4)].Thrombosis is a recognized potential complication of prosthetic valve implantation potentially leading to explantation; therefore, adequate anticoagulation is required of recipients of the on-x valve in the mitral position [instructions for use].The root cause of the thrombotic material adherent to the valve cuff is unknown.However, inadequate anticoagulation and/or poor patient compliance are likely explanations.  thromboembolic events are not an unexpected adverse event for mechanical heart valves.The ifu lists prosthesis thrombosis as a known potential risk associated with the use of the on-x valve.No further action necessary.This event does not identify additional hazards or modify the probability and severity of existing hazards.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

Information received, "mitral valve was thought to be compromised due to clot on sewing ring of the valve.Mitral valve was removed and a new valve was implanted.".

• Brand Name: ONX MITRAL STANDARD 25
• 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 TECHNOLGIES, INC; 1300 e. anderson ln.; bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144
• MDR Report Key: 6897836
• MDR Text Key: 87525868
• Report Number: 1649833-2017-00071
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2014
• Device Model Number: ONXM-25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/30/2017
• Date Manufacturer Received: 08/30/2017
• 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; Other
• Patient Age: 48 YR
• Patient Weight: 57