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

Model Number UNKNOWN

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

Patient Problems Bruise/Contusion (1754); Aortic Dissection (2491)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Initial reports on 02/22/2017 allege "the annulus was sized and then the onx aortic valve inserted and the annulus root ruptured and the device had to be taken out and the root sewn up and a different aortic valve implanted." according to information received from the surgeon (b)(6) 2017, based on ¿black¿ sizer measurement, the doctor used a 21mm on-x aortic valve.Placing the valve was "a squeeze".Once taken off bypass, the doctor noticed "bruising and bleeding".The valve was removed and replaced with a 19mm from another company.According to the doctor, after time in the icu, the patient is doing well and is home.

Manufacturer Narrative

Multiple attempts were made to obtain the valve serial number; however, all attempts were unsuccessful.A review of the available information was performed.Purported on-x aortic heart valve size 21 mm implant attempted following "black" sizer indication for this size.Fit was "a squeeze".Taken off bypass, the surgeon noted "bruising and bleeding"; re-exploration indicated that the annulus root had ruptured.Bypass was reinstituted, the on-x valve was explanted, aortic root repaired, and patient fitted with an unidentified competitor 19 mm valve.No valve specific information was provided to verify the identity of the on-x valve.The "black" sizer set refers to the translucent grey i2 instrument configuration whose profile end is an exact replica of the valve dimensions.The notation that the fit was "a squeeze" points strongly to a case of oversizing which is explicitly warned against in boldface in the instructions for use: "caution: avoid oversizing the valve, as this could lead to interference with valve function." in this case, the oversizing placed too much strain on the annulus, compromising its integrity.Root cause for this event is oversizing of the valve.

Event Description

Initial reports on 02/22/2017 allege "the annulus was sized and then the onx aortic valve inserted and the annulus root ruptured and the device had to be taken out and the root sewn up and a different aortic valve implanted." according to information received from the surgeon 02/28/2017, based on ¿black¿ sizer measurement, the doctor used a 21 mm on-x aortic valve.Placing the valve was "a squeeze".Once taken off bypass, the doctor noticed "bruising and bleeding".The valve was removed and replaced with a 19 mm from another company.According to the doctor, after time in the icu, the patient is doing well and is home.

• Brand Name: ON-X AORTIC VALVE
• 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, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd; kennesaw, GA 30144
• MDR Report Key: 6430975
• MDR Text Key: 70743232
• Report Number: 1649833-2017-00028
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/22/2017
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Other