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

Model Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Thrombus (2101)

Event Date 12/20/2018

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 initial reports, a patient was admitted in (b)(6) 2018 with thrombosis of an on-x aortic valve prosthesis.The valve was explanted and replaced with a valve from a different manufacturer.

Manufacturer Narrative

A review of the available information was performed.A diagnosis of thrombosis for an unidentified on-x valve placed into the aortic position of a male patient was reported from scotland.We do not have any objective medical records to corroborate the assessment.The valve was not returned to the manufacture for evaluation.Complainant states that patient was advised to take warfarin with an inr range of 1.5 - 2.0, but was not informed about doing so only after 3-months postop and complementing the warfarin with low dose aspirin.We do not have a date of surgery, so we do not know the elapsed time until the thrombosis was diagnosed.And although we are told the patient was advised to maintain an inr of 1.5 - 2.0, we do not know what it actually was leading up to the event.But the complainant states that the patient was not taking aspirin and appears to have been started on the lower inr immediately after surgery.The valve was explanted and replaced with another non-on-x valve.The outcome of this re-operation was not given.The information provided suggests an aortic on-x valve thrombosed following inadequate anticoagulation therapy.Thrombosis is a rare, but a known potential complication of prosthetic valve replacement [ifu] occurring at a historical rate of 0.8% per patient-year for rigid heart valves [iso 5840:2005e].The ifu states the recommended anticoagulation therapy (section 6 "individualization of treatment: anticoagulation") and also acknowledges the possibility of complications such as thrombosis with the potential for reoperation and explantation.This is a case of valve thrombosis, but we do not know the origin nor age of the clot.The information provided points to inadequate anticoagulation as the likely cause.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

According to initial reports , a patient was admitted in (b)(6) 2018 with thrombosis of an on-x aortic valve prosthesis.The valve was explanted and replaced with a valve from a different manufacturer.

Manufacturer Narrative

A review of the available information was performed.A diagnosis of thrombosis for an unidentified on-x valve placed into the aortic position of a male patient was reported from scotland.We do not have any objective medical records to corroborate the assessment.The valve was not returned to the manufacture for evaluation.Complainant states that patient was advised to take warfarin with an inr range of 1.5 - 2.0 but was not informed about doing so only after 3-months postop and complementing the warfarin with low dose aspirin.We do not have a date of surgery, so we do not know the elapsed time until the thrombosis was diagnosed.And although we are told the patient was advised to maintain an inr of 1.5 - 2.0, we do not know what it was leading up to the event.But the complainant states that the patient was not taking aspirin and appears to have been started on the lower inr immediately after surgery.The valve was explanted and replaced with another non-on-x valve.Additional information provided after the initial submission of this report indicates that the patient was recovering well and that the valve might have been repairable rather than replaced, but in the end made the call to explant.The information provided suggests an aortic on-x valve thrombosed following inadequate anticoagulation therapy.Thrombosis is a rare but known potential complication of prosthetic valve replacement [ifu] occurring at a historical rate of 0.8% per patient-year for rigid heart valves [iso 5840:2005e].The ifu states the recommended anticoagulation therapy (section 6 "individualization of treatment: anticoagulation") and acknowledges the possibility of complications such as thrombosis with the potential for reoperation and explantation.This is a case of valve thrombosis, but we do not know the origin nor age of the clot.The information provided points to inadequate anticoagulation as the likely cause.No further action is required without additional information.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

According to initial reports , a patient was admitted in (b)(6) 2018 with thrombosis of an on-x aortic valve prosthesis.The valve was explanted and replaced with a valve from a different manufacturer.

• Brand Name: ON-X PROSTHETIC AORTIC VALVE UNKNOWN CONFIGURATION
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; ste 110; austin TX 78752
• MDR Report Key: 8339726
• MDR Text Key: 136162013
• Report Number: 1649833-2019-00008
• 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: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/13/2019
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention