MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC AORTIC VALVE WITH STANDARD SEWING RING AND EXTENDED HOLDER; HEART-VALVE, MECHANICAL

Model Number ONXAE-27/29

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Embolism (1829); Weakness (2145); No Code Available (3191)

Event Date 04/09/2019

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 initial report, the patient suffered a stroke in (b)(6) 2019.Records indicate the patient had the onxae-27/29 implanted on (b)(6) 2016.Patient received tissue plasminogen activator and thrombectomy at another hospital.Still has some residual aphasia.Weakness is resolved.Patient's inr was stable at 1.6 and he was on 81mg aspirin.

Manufacturer Narrative

The manufacturing records for the packaging of valve onxae-27/29 serial number (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-conformances or deviations were noted.A review of the available information was performed.Onxae-27/29 sn (b)(4) was implanted october 7th, 2016.The patient experienced a stroke on april 9th, 2019.The patient's inr is reported to have been 1.6 at the time and had been consistently taking 81mg aspirin.The patient¿s documented historical inr¿s were in the 1.6 ¿ 2.0 range.An inr of 1.8 (range 1.5 ¿ 2.0) plus 75-100mg aspirin daily for the isolated on-x aortic valve is the current recommendation [ifu, nishimura 2017].Stroke is a recognized potential adverse event [ifu] and for rigid heart valve replacement, the rate of occurrence is 3.0 %/valve-year [iso 5840:2005].Thromboembolism is a recognized potential adverse event for any mechanical aortic heart valve recipient.With the information provided, as the patient was on anticoagulation due to a mechanical prosthesis, the first consideration for a source is the valve.No further action is required at this time.Should additional information become available, it will be evaluated and the complaint will be reopened.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 the report, the patient suffered a middle cerebral artery stroke in (b)(6) 2019.Records indicate the patient had the onxae-27/29 implanted on (b)(6) 2016.Patient received tissue plasminogen activator and thrombectomy at another hospital.Still has some residual aphasia.Weakness is resolved following aggressive therapy.Patient's inr was stable at 1.6 and he was on 81mg aspirin at the time of the event.

• Brand Name: ON-X PROSTHETIC AORTIC VALVE WITH STANDARD SEWING RING AND EXTENDED HOLDER
• 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: 8724660
• MDR Text Key: 148921381
• Report Number: 1649833-2019-00040
• 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
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/31/2019
• Device Model Number: ONXAE-27/29
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/29/2019
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR