MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES ON-X AORTIC CONFORM EXT 21; HEART-VALVE, MECHANICAL

Model Number ONXACE-21

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

Patient Problems Embolism (1829); Thrombosis (2100)

Event Date 07/03/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The email stated that the patient received an onxace-21 12-18 months ago and developed a thrombosis of one leaflet that embolized to his coronary artery it was stated that the patient (a (b)(6) male) had been kept in the target range of inr.The date of incident i placed is the date that (surgeon) was informed regarding this patient.It is possible that the actual date of incident may be different, i.E.Earlier.

Manufacturer Narrative

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

The email stated that the patient received an onxace-21, 12-18 months ago and developed a thrombosis of one leaflet that embolized to his coronary artery.It was stated that the patient (a 60-year old male) had been kept in the target range of inr.The date of the incident i placed is the date that (surgeon) was infomred regarding this patient.It is possible that the actual date of the incident may be different, i.E.Earlier.

Manufacturer Narrative

Initial email from dr.(b)(6) stated, ¿we found out today that a 60-year old male in whom we placed a 21mm on-x valve about 1 ½ years ago, just suffered thrombosis of one leaflet and embolized to his coronary artery.He had been kept in the target range of inr.¿ the nurse stated the patient ¿he was within the 1.5-2.0 range; i believe his inr was 1.8 a few weeks ago.¿ clinical/medical performed a review of the available information.This is a case of alleged thromboembolism per the surgeon, occurring approximately 1-1 ½ years post op.A definitive date of implant and occurrence is unknown.Inr was noted to be within the acceptable lower inr range of 1.5-2.0 per the nurse.Other patient comorbidities or clarifying information is unavailable.Root cause for the initial thrombosis and subsequent embolism is unknown based on available information.The on-x instructions for use acknowledges the risks of thromboembolism and thrombosis with subsequent reoperation and explanation as potential complications [ifu].Thromboembolism and thrombosis are relatively rare occurrences.Objective performance criteria list rates of 3.0 and 0.8% / patient-year, respectively, for rigid heart valve substitutes [iso5840:2005].References: iso5840:2005 (e) cardiovascular implants-cardiac valve prosthesis, annex r.2.On-x instructions for use including aortic valve inr 1.5-2.0 update.(b)(4).Root cause for the initial thrombosis and subsequent embolism is unknown based on the available information.No further action is required at this time.The on-x valve risk management file 940816 01 rev.Am 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.The ifu lists prosthesis thrombosis as a known potential risk associated with the use of the on-x valve.Per clinical/medical report, the cause of the event is unknown based on the available information.Thromboembolic events are a recognized risk factor for mechanical heart valve replacement as stated in section 5 of the ifu.The on-x 614 heart valve design fmea has described the event outcome addressed in section 5, 5a through 5e*.Thrombosis is a monitored event and is assessed in the biannual risk assessment for the on-x heart valve.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

The email stated that the patient received an onxace-21, 12-18 months ago and developed a thrombosis of one leaflet that embolized to his coronary artery.It was stated that the patient (60-year old male) had been kept in the target range of inr.The date of the incident i placed is the date that (surgeon) was informed regrading this patient.It is possible that the actual date of the incident may be different, i.E.Earlier.

• Brand Name: ON-X AORTIC CONFORM EXT 21
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES; 1300 e. anderson ln. bldg. b; austin TX 78752
• MDR Report Key: 8991788
• MDR Text Key: 161220447
• Report Number: 1649833-2019-00053
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ONXACE-21
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/04/2019
• Initial Date Manufacturer Received: 07/04/2019
• Initial Date FDA Received: 09/11/2019
• Supplement Dates Manufacturer Received: 07/04/2019; 07/04/2019
• Supplement Dates FDA Received: 10/02/2019; 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 60 YR