MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC STANDARD 23; HEART-VALVE, MECHANICAL

Model Number ONXA-23

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 03/13/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

"as discussed with [doctor] he said that all the surgery went well and they placed onx aortic valve size 23 in the patients heart.When they closed the heart, they have checked patients heart with eco machine and one of the leaflet wasn't moving at that time.[doctor] had to reopen the aorta and in order to reach onx valve and replace it with the nearest size of onx aortic valve.".

Manufacturer Narrative

According to the report: "as discussed with doctor, he said that all the surgery went well and they placed onx aortic valve size 23 in the patient¿s heart.When they closed the heart, they have checked patient¿s heart with eco machine and one of the leaflet wasn't moving at that time.Doctor had to reopen the aorta and in order to reach onx valve and replace it with the nearest size of onx aortic valve." the reported event involves an onxa-23 with the serial number (b)(4).Multiple attempts were made to complainant to retrieve additional information with no success.The onxa-23 valve, serial number (b)(4) was evaluated.The sub-assembly inspections and component dimensional inspection indicate that the valve meets all specifications and that the reported event could be contributed to physiological interference.A manufacturing review was performed for the valve.It was confirmed that all records were controlled, available for review, and met all specifications.All lots passed functional testing and met release specifications.No non-conformances or deviations were noted.A review was performed of the available information.Onxa-23, serial number (b)(4) was implanted/explanted on (b)(6) 2017.After closing the aorta at surgery, an echocardiogram indicated that one of the two leaflets was not moving.The valve was removed and replaced with another on-x valve (unidentified).The explanted valve was returned to the manufacturer for analysis where dimensional and functional tests report all normal readings.The most likely cause of an immobile leaflet for a valve that is otherwise fully within specifications is some sort of anatomic or physical interference.The site reports do not identify any such interference; however, there is not enough information.By extension, not enough information is presented to ascertain what, if any, relationship the valve has to the immobility of its leaflet.

Event Description

As discussed with doctor he said that all the surgery went well and they placed onx aortic valve size 23 in the patients heart.When they closed the heart, they have checked patients heart with eco machine and one of the leaflet wasn't moving at that time.Doctor had to reopen the aorta and in order to reach onx valve and replace it with the nearest size of onx aortic valve.

• Brand Name: ONX AORTIC STANDARD 23
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd. nw; kennesaw, GA 30144
• MDR Report Key: 6544091
• MDR Text Key: 74410055
• Report Number: 1649833-2017-00046
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXA-23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/06/2017
• Date Manufacturer Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention