MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL STANDARD 25; HEART-VALVE, MECHANICAL

Model Number ONXM-25

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

Patient Problems Atrial Fibrillation (1729); Thrombosis (2100)

Event Date 04/24/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Per the initial notification, "we have received a report of a problem at [hospital] on an on-x heart valve that has had to be replaced on the patient below." valve implanted on (b)(6) 2015 and was replaced on (b)(6) 2018.According to the distributor, "the one leaflet was moving normally but the other leaflet was immobile.There were no obvious clots related to the hinge mechanises (mechanism).It needs to be examined very carefully to see if there was any clot in the hinge mechanism.".

Manufacturer Narrative

The explanted valve was not returned, so no direct observation could be made.Onxm-25 sn (b)(4) implanted (b)(6)2015 in the mitral position of a 35 year old female with paroxysmal atrial fibrillation.Valve was explanted and replaced (b)(6)2018 (2 years 270 days post-implant) with onxm-27/29 sn (b)(4) following diagnosis of suspected thrombosis.Distributor states one leaflet was moving normally but the other leaflet was immobile.The source of this observation is not stated, but is likely an echocardiogram.Upon re-operation, the operative report states ¿no clot or thrombus noted in prosthesis.No clot in atrium.Presence and fibrotic tissue on ventricular side of thrombosis.¿ the meaning of this last sentence is unclear.No inr history data is available so we do not know the anticoagulation status of the patient and its contribution to a potential clot.The valve was not returned for observation therefore, we are left with the operative report of no clotting observed which leads to the current likelihood that the immobile leaflet was being obstructed anatomically.That may be the implication of the unclear sentence, i.E.Fibrotic tissue on the ventricular side of the prosthesis, which could impinge on leaflet movement.So, we may have a thrombosed valve or we may have an obstructed leaflet due to fibrotic tissue impingement.The information is inadequate to draw a definitive conclusion and so we do not have enough information to ascertain what, if anything, the valve contributes to the decision for its explantation and replacement.The instructions for use, meanwhile, indicate that thrombosis, non-structural prosthetic dysfunction (e.G.Impingement), reoperation, and explantation are all possible outcomes of mechanical prosthetic valve replacement [ifu].Immobilized leaflet due to possible thrombus or leaflet impingement.Insufficient information to determine source of obstruction.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

Per the initial notification, "we have received a report of a problem at [hospital] on an on-x heart valve that has had to be replaced on the patient below." valve implanted on (b)(6)2015 and was replaced on (b)(6)2018.According to the distributor, "the one leaflet was moving normally but the other leaflet was immobile.There were no obvious clots related to the hinge mechanises [mechanism].It needs to be examined very carefully to see if there was any clot in the hinge mechanism.".

• Brand Name: ONX MITRAL STANDARD 25
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg b; bldg. b; austin TX 78752
• MDR Report Key: 7523697
• MDR Text Key: 108610256
• Report Number: 1649833-2018-00034
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2019
• Device Model Number: ONXM-25
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/17/2018
• Distributor Facility Aware Date: 04/26/2018
• Date Manufacturer Received: 04/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR