MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC AORTIC VALVE; HEART-VALVE, MECHANICAL

Model Number ONXAC-21

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

Patient Problem Thrombosis (2100)

Event Date 02/18/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the initial report, patient, female, on-x aortic implantation 2004.(b)(6) inr >2.5.2-3 weeks ago thrombosis.After treatment patient is well again.Additional information received relays that the patient had the onxac-21 implanted on (b)(6) 2004 due to high-grade as (bicuspid aortic valve, sievers type i).The patient was hospitalized on (b)(6) 2019 to (b)(6) 2019.The patient's symptoms were dyspnea, vertigo, cardiac decompression.During the hospitalization the patient had an ecg that showed af (atrial fibrillation), pvc (premature ventricular contraction), heart rate 30bpm.A blood test showed inr: 2.7, crp: 27mg/l, trop t: 22.44 ng/l, nt-pro-bnp: 1431 ng/l.Tte showed restricted leaflet motion, av vmax: 3.6 m/s, av ppg: 52mm hg, ef: 48%, tr, tv max: 3.5 m/s, tv ppg: 65mm hg.Tee showed restricted leaflet motion, av vmax: 3.5 m/s, ppg: 48mm hg.Therapy performed: ufh (unfractionated heparin) perfusion and injection.Follow-up: osc (oral anticoagulant) plus antiplatelet (marcoumar plus thromboass, target inr: 2-3), re-evaluation in 3 months.Echo images have been requested from referring hospital.

Event Description

According to the initial report, patient, female, on-x aortic implantation 2004.Inr >2.5.2-3 weeks ago thrombosis.After treatment patient is well again.Additional information received relays that the patient had the onxac-21 implanted on (b)(6) 2004 due to high-grade as (bicuspid aortic valve, sievers type i).The patient was hospitalized on (b)(6) 2019 to (b)(6) 2019.The patient's symptoms were dyspnea, vertigo, cardiac decompression.During the hospitalization the patient had an ecg that showed af (atrial fibrillation), pvc (premature ventricular contraction), heart rate 30bpm.A blood test showed inr: 2.7, crp: 27mg/l, trop t: 22.44 ng/l, nt-pro-bnp: 1431 ng/l.Tte showed restricted leaflet motion, av vmax: 3.6 m/s, av ppg: 52mm hg, ef: 48%, tr, tv max: 3.5 m/s, tv ppg: 65mm hg.Tee showed restricted leaflet motion, av vmax: 3.5 m/s, ppg: 48mm hg.Therapy performed: ufh (unfractionated heparin) perfusion and injection.Follow-up: osc (oral anticoagulant) plus antiplatelet (marcoumar plus thromboass, target inr: 2-3), re-evaluation in 3 months.Echo images have been requested from referring hospital.

Manufacturer Narrative

A root cause for the reported event is thrombosis, but we do not know the origin of the clot.The abnormal cardiac rhythm may be a contributing factor in its formation but we otherwise do not have clear evidence of what, if any, contribution the valve had to it.The manufacturing records were reviewed and it was confirmed that all records were controlled, available for review, and met specifications prior to release.Thromboembolic events are a recognized risk factor for mechanical heart valve replacement.The risk management file 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.There is no indication that an error or deficiency occurred at cryolife, inc.And the ifu adequately communicates risk.No further action is 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.

• Brand Name: ON-X PROSTHETIC AORTIC VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 8464269
• MDR Text Key: 140311096
• Report Number: 1649833-2019-00021
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/31/2008
• Device Model Number: ONXAC-21
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other