MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC MITRAL VALVE WITH CONFORM-X SEWING RING; HEART-VALVE, MECHANICAL

Model Number ONXM-25

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Aneurysm (1708); Embolism (1829)

Event Date 10/22/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to reports, the patient was admitted to the hospital on (b)(6) 2018 with right hemiparesis and was diagnosed with a cerebrovascular accident.The patient had anticoagulation stopped 7 days previously because of over anticoagulation.The inr on admission to hospital was 1.12 on (b)(6) 2018.The patient was diagnosed with a cerebrovascular accident with investigation revealing an infarct in the territory of the left middle cerebral artery.The patient presented on admission to hospital on (b)(6) 2018 with right sided weakness and seizures.The cerebrovascular accident study complication was fatal on (b)(6) 2018.

Event Description

According to reports, the patient was admitted to the hospital on (b)(6) 2018 with right hemiparesis and was diagnosed with a cerebrovascular accident.The patient had anticoagulation stopped 7 days previously because of over anticoagulation.The inr on admission to the hospital was 1.12 on (b)(6) 2018.The patient was diagnosed with a cerebrovascular accident with investigation revealing an infarct in the territory of the left middle cerebral artery.The patient presented on admission to hospital on (b)(6) 2018 with right sided weakness and seizures.The cerebrovascular accident study complication was fatal on (b)(6) 2018.

Manufacturer Narrative

Correction - the valve was mitral not aortic.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.A review of the available information was performed.Maintaining the proper balance of anticoagulant is critical.Unless contraindicated, patients with an on-x valve in the aortic valve position should be maintained on long-term warfarin anticoagulation which should achieve an inr of 2.0 - 3.0 for the first 3 months after valve replacement surgery, after which the inr should be reduced to 1.5 - 2.0 [ifu].Thrombosis, thromboembolism, and death are all recognized risk factors for mechanical mitral valve replacement cases [instructions for use].Objective performance criteria report an historical thrombosis incidence of 0.8% per valve-year for all rigid prosthetic valves [iso 5840:2005] while the guidelines state that even with adequate anticoagulation the risk of thromboemboli is 1% - 2% per year [nishimura].Root cause for this event is sub-therapeutic anticoagulation causing formation of clot which embolized leading to a thromboembolic stroke and subsequent death.No further action is warranted at this time.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 MITRAL VALVE WITH CONFORM-X SEWING RING
• 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: 8277996
• MDR Text Key: 134105475
• Report Number: 1649833-2019-00003
• 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: 04/14/2019

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: No Information
• Device Expiration Date: 09/05/2019
• Device Model Number: ONXM-25
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/12/2019
• Initial Date Manufacturer Received: 01/12/2019
• Initial Date FDA Received: 01/25/2019
• Supplement Dates Manufacturer Received: 01/12/2019
• Supplement Dates FDA Received: 04/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 67 YR