MAUDE Adverse Event Report: ONX LIFE TECHNOLOGIES ONX AORTIC CONFORM 27/29MM; HEART VALVE MECHANICAL

Model Number ONXAC-27/29

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

Patient Problem Aneurysm (1708)

Event Date 01/20/2017

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 implant registration cards onxac-27/29 sn (b)(4), implanted (b)(6) 2003 was explanted (b)(6) 2017 and replaced with onxaap-27/29.Operative notes have been received and reviewed and contain the following information; "we inspected the valve.Interestingly there was thrombus along the sewing ring of the valve circumferentially.We were able to identify thrombus both on the aortic side but also on the ventricular side.In retrospect, this may have been responsible for the patient's stroke with the coronary angiogram.We decided that given the thrombus burden we would replace this valve as well.The valve was resected using a combination of # 11 blade and metzenbaum scissors.The aortic root was quite dilated as predicted and the left coronary button was harvested.We explored the right coronary button which was occluded a few millimeters beyond the ostium.We decided that we would not reimplant this button.We then sized the annulus and chose a #27 and #29 on-x aap prosthesis.".

Manufacturer Narrative

The manufacturing records for the onxac-27/29 sn (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.The onxac-27/29 sn (b)(4) implanted (b)(6) 2003 in the aortic position.It was explanted and replaced by an onxaap-27/29 sn (b)(4) on (b)(6) 2017 (13 years 30 days postop).The operative report for the reoperation was made available.In it we find that the initial diagnosis recommended replacement of the aorta due to aortic aneurysm.The patient suffered a "stroke" (from which he fully recovered) while undergoing a coronary angiogram to assess the patency of his native coronary arteries and a previously placed lima (left internal mammary artery) coronary artery bypass graft (cabg).During surgery, thrombotic material was observed circumferentially along the cuff around the original on-x valve on both inflow and outflow sides.The surgeon speculated this as the source of thromboembolic material precipitating the "stroke" and decided at this point to replace not only the aorta, but also the prosthetic valve using an integrated model of the on-x valve incorporating the valve and aortic graft as one device (onxaap).While thrombotic material was observed on the sewing cuff of the original aortic valve prosthesis during surgery, it had not grown large enough to interfere with the valve's function and the patient was asymptomatic with respect to that anomaly.Replacing the original valve was a preemptive measure against a possible future thrombosis or pannus complication.Reoperation for complications leading to explantation is recognized in the instructions for use.Although a complication had not yet occurred, the increased potential for one in the future certainly influenced the decision of the surgeon to replace the valve now while the opportunity was at hand.As the patient was asymptomatic with respect to his original prosthetic valve, its replacement was likely a preventive action against a potential future valvular dysfunction.The root cause for this event is unknown.No further action is warranted at this time.

Event Description

According to implant registration cards onxac27/ 29 sn (b)(4), implanted (b)(6) 2003 was explanted (b)(6) 2017 and replaced with onxaap27/ 29.Operative notes have been received and reviewed and contain the following information; "we inspected the valve.Interestingly there was thrombus along the sewing ring of the valve circumferentially.We were able to identify thrombus both on the aortic side but also on the ventricular side.In retrospect, this may have been responsible for the patient's stroke with the coronary angiogram.We decided that given the thrombus burden we would replace this valve as well.The valve was resected using a combination of # 11 blade and metzenbaum scissors.The aortic root was quite dilated as predicted and the left coronary button was harvested.We explored the right coronary button which was occluded a few millimeters beyond the ostium.We decided that we would not reimplant this button.We then sized the annulus and chose a #27 and #29 onx aap prosthesis.".

• Brand Name: ONX AORTIC CONFORM 27/29MM
• Type of Device: HEART VALVE MECHANICAL
• Manufacturer (Section D): ONX LIFE TECHNOLOGIES; 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: 6391317
• MDR Text Key: 69486388
• Report Number: 1649833-2017-00023
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXAC-27/29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/07/2017
• Date Manufacturer Received: 02/07/2017
• 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): Required Intervention
• Patient Age: 61 YR