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

Model Number ONXACE-21

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

Patient Problems Chest Pain (1776); Thrombus (2101)

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.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 initial report, "patient experienced chest pain.Brought to cath lab on (b)(6) 2019.Determined he had infarct.Thrombus discovered on valve leaflet and circumflex.Termed as organized clot.One of the two leaflets [leaflets] not opening.Treated [treated] with thrombolytic therapy.One leaflet [leaflet] still closed on (b)(6) 2019.Valve leaflet determined open on (b)(6) 2019.Patient now stable.".

Event Description

According to the initial report, "patient experienced chest pain.Brought to cath lab on (b)(6) 2019.Determined he had infarct.Thrombus discovered on valve leaflet and circumflex.Termed as organized clot.One of the two leadflets [leaflets] not opening.Traeted [treated] with thrombolytic therapy.One leadflet [leaflet] still closed on (b)(6) 2019.Valve leaflet determined open on (b)(6) 2019.Patient now stable.".

Manufacturer Narrative

The manufacturing records for the onxace-21 sn (b)(6) 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.Onxace-21 sn (b)(6) was implanted in the aortic position of a 60.5-year-old male patient on (b)(6) 2018.On (b)(6) 2019 (1 year 141 days post implant) the patient experienced chest pain.Catheter lab diagnosis was infarct, but results also indicated thrombus (clot) on a valve leaflet and circumflex.One of the leaflets was not opening.Identified as organized clot, the patient was treated with thrombolytic therapy in an attempt to dissolve the clot(s).After two days one leaflet was still closed, but after 7 days it was announced as open.Patient now stable.Anticoagulation target was inr [international normalized ratio] 1.8 (range 1.5-2.0), but the inr at the time of the event and historical compliance with prescribed therapy was not provided.An organized clot suggests the thrombus grew in place and was not simply lodged in the valve after forming elsewhere.This, then, means it is anticoagulation therapy issue, and while we know the target inr range, which appears to be in agreement with recommendations contained in the instructions for use [ifu], we do not know the historical compliance.We also do not know if the patient has a hypercoagulable blood chemistry.So, while we can classify this as a thrombosis, we don¿t really have enough information to clearly indicate the cause of the clot¿s formation and therefore cannot say for certain what contribution the valve had to the event.The proact study results, from which the recommended inr range was derived, still experienced thromboses, but at a rate no different from patients undergoing the former standard-of-care (inr 2.0-3.0).Indeed, there were two cases for each of the control and treatment groups for a non-significant statistical event rate of 0.18 and 0.21 % per patient-year, respectively [puskas 2018].Thrombosis is a rare, but known potential complication of prosthetic valve replacement [ifu] occurring in the ¿real world¿ at a historical rate of 0.8% per patient-year for rigid heart valves.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: ONX AORTIC CONFORM EXT 21
• 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: 8859975
• MDR Text Key: 153437036
• Report Number: 1649833-2019-00050
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001457
• UDI-Public: 00851788001457
• 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
• Type of Report: Initial,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2023
• Device Model Number: ONXACE-21
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/10/2019
• Date Manufacturer Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 61 YR