MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X MITRAL HEART VALVE WITH CONFORM-X SEWING RING -25/33; HEART-VALVE, MECHANICAL

Model Number ONXMC-25/33

Device Problems Perivalvular Leak (1457); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Congenital Defect/Deformity (1782); No Code Available (3191)

Event Date 08/31/2016

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 the initial report on 08/31/2016, "surgeon replied to an email i sent him.He said that he had to do a re-op on a patient with a perivalvular leak in the mitral position.Email is below: 'i have reservations about this valve, particularly in the mitral position.We have reoperated on a thrombosed valve recently.In addition, i will reoperate on a patient next week with a severe periprosthetic leak.Both reoperations have (or will) occurred within one year of original implant.In my practice, the implantation of mechanical valves are rare.In so far as possible, i try to avoid them.'" the rep stated that the "thrombosed valve he mentions was reported already" as a separate complaint.The rep also confirmed that the valve in question was an on-x valve. additional information received indicated that the valve was implanted (b)(6) 2015.Dr.Turner did not explant that valve after all.What he found was an asd that he fixed with suture.They came off pump and watched the valve for a bit to make sure that everything was working properly and then they pulled the cannula's and closed him up.Patient did fine and nothing was done to the valve itself.

Manufacturer Narrative

Brand name and model #/lot # updated to reflect correct product size.The rep forwarded another email from the nurse on 09/19/2016 that stated the surgeon "did not explant that valve after all.What he found was an asd [atrial septal defect] that he fixed with suture.They came off pump and watched the valve for a bit to make sure that everything was working properly and then they pulled the cannula's and closed him up.Patient did fine and nothing was done to the valve itself.¿ the manufacturing records for the onxmc-25/33, 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.The onxmc-25/33, sn (b)(4) was implanted (b)(6) 2015 and required reoperation on (b)(6) 2016 for possible pvl.Upon reoperation, the diagnosis of pvl was found to be erroneous; the "leak" was due to an asd.Normally a congenital condition, asd's can persist without detection into adulthood.An asd shunt jet could be very close to where a pvl jet might appear on echo and so defect proximity to the valve plane may have contributed to the misdiagnosis.The valve was left in place, the asd was sutured shut, and the patient exhibited no further complications.This is not a valve-related event.

Manufacturer Narrative

Additional information from the physician stated, ¿i repaired the pvl but did not seel [say] it was an asd.Looked like a plain pvl.¿ the rep clarified, ¿i spoke to the surgeon after this letter was sent out.The information i got originally, was that it was an asd as stated.Today he told me that it was not an asd but in fact a pvl due to surgeon technique.The on-x mv was left in place and he corrected the pvl.¿ the manufacturing records for the onxmc-25/33, 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.The onxmc-25/33, sn (b)(4), was implanted on (b)(6) 2015 and reoperation was performed (b)(6) 2016 for possible pvl.Originally attributed to a leaking atrial septal defect, follow-up information from the surgeon states that this was a pvl due to surgical technique which was corrected upon re-operation (1 year 230 days post-implant) and the mitral valve was left in place.Pvl is a recognized potential adverse event of prosthetic valve implantation and is indicated in the instructions for use (ifu).The root cause in this case was explicitly stated to be surgical technique which was corrected with strategic suture placement.This event does not identify additional hazards or modify the probability and severity of existing hazards.

Event Description

According to the initial report on 08/31/2016, "surgeon replied to an email i sent him.He said that he had to do a re-op on a patient with a perivalvular leak [pvl] in the mitral position.Email is below: 'i have reservations about this valve, particularly in the mitral position.We have reoperated on a thrombosed valve recently.In addition, i will reoperate on a patient next week with a severe periprosthetic leak.Both reoperations have (or will) occurred within one year of original implant.In my practice, the implantation of mechanical valves are rare.In so far as possible, i try to avoid them.'" the rep stated that the "thrombosed valve he mentions was reported already" as a separate complaint.The rep also confirmed that the valve in question was an on-x valve.Additional information received indicated that the valve was implanted (b)(6) 2015.The rep stated that the surgeon "did not explant that valve after all.What he found was an asd [atrial septal defect] that he fixed with suture.They came off pump and watched the valve for a bit to make sure that everything was working properly and then they pulled the cannula's and closed him up.Patient did fine and nothing was done to the valve itself.¿ additional information received from the surgeon indicated that the original information presented for the case was incorrect.He stated ¿i repaired the pvl but did not seel [say] it was an asd.Looked like a plain pvl.¿ the rep clarified via email on 12/20/2016, ¿i spoke to the surgeon after this letter [email] was sent out.The information i got originally, was that it was an asd as stated.Today he told me that it was not an asd but in fact a pvl due to surgeon technique.The on-x mv was left in place and he corrected the pvl.¿.

• Brand Name: ON-X MITRAL HEART VALVE WITH CONFORM-X SEWING RING -25/33
• 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 nw; kennesaw, GA 30144
• MDR Report Key: 5986428
• MDR Text Key: 55885986
• Report Number: 1649833-2016-00058
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/23/2019
• Device Model Number: ONXMC-25/33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/31/2016
• Date Manufacturer Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 46 YR