MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X AORTIC HEART VALVE WITH EXTENDED HOLDER 21MM; HEART-VALVE, MECHANICAL

Model Number ONXAE-21

Device Problems Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 01/17/2017

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 the forwarded email by the rep from the iranian on-x distributor, the following was reported for an onxae-21 (sn (b)(4)) occurring on (b)(6) 2017, "while mvr [mitral valve replacement]surgery was being performed on a (b)(6) male diagnosed with sever ms [mitral stenosis], moderate ai [aortic insufficiency] & severe cad [coronary artery disease], [the surgeon] noticed that the on-x valve mentioned above was missing one leaflet.They immediately replaced the on-x valve with a st.Jude and found the broken pieces of the leaflet in patient¿s left ventricle." the following additional information was requested, answers in quotes: was this aortic valve implanted into the mitral position? "no, the on-x aortic valve was implanted in aortic position." can you clarify at what point during the procedure the valve was discovered to have a missing leaflet? "dr.Said 'it was aortic view, superior position'".Before suturing in, after, etc? "the valve has been implanted completely so it was after suturing." did any metal surgical instruments come in contact with the leaflets? "no" was leaflet function tested with the provided leaflet probe in the instrument kit? "yes, he always uses on-x leaflet probe." what is the current patient status? "he is fine"."also this letter has been written by dr.(b)(6) which has expounded the details of the operation - 'a (b)(6) patient was a candid of mvr-avr-cabg.A st.Jude mitral valve was implanted and when the on-x valve was completely implanted, i noticed the absence of one of the leaflets.Therefore, the implanted valve was taken out immediately and we found the 2 un-even broken pieces of the leaflets in the lv [left ventricle].My viewing approach was from a superior position & aortic view and based on this approach we were able to emit the two pieces from the lv.'".

Manufacturer Narrative

A sample review was performed for the onxae-21, (b)(4), by a product engineer, on  via gross visual examination and sem (scanning electron microscopy) and eds (energy-dispersive x-ray spectroscopy) by a third-party lab.There is no evidence of metallic instrumentation contact with the valve.The noted leaflet fracture is an overload fracture with its origin at the inflow side of the major radius.Given that a properly sized rotator will not engage the leaflets, it appears that this fracture occurred during a rotation and it is likely that an undersized rotator was used.Past examples of this fracture mode is indicative of the use of an undersized rotator when rotating the valve.A scratch was noted on the housing internal diameter (id) and could be a result of the broken leaflet being ejected at the time of the fracture.The manufacturing records for the onxae-21, (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.Evidence gathered in the sample review concludes that the valve leaflet was subjected to excessive force, likely during rotation with an undersized rotator.The ifu states ¿avoid damaging the prosthesis through the application of excessive force to the valve orifice or leaflets.¿ this event does not identify additional hazards or modify the probability and severity of existing hazards.

Event Description

According to the forwarded email by the rep from the (b)(4) on-x distributor, the following was reported for an onxae-21 ((b)(4)) occurring on (b)(6) 2017, "while mvr [mitral valve replacement] surgery was being performed on a (b)(6) male diagnosed with sever ms [mitral stenosis], moderate ai [aortic insufficiency] & severe cad [coronary artery disease], [the surgeon] noticed that the on-x valve mentioned above was missing one leaflet.They immediately replaced the on-x valve with a st.Jude and found the broken pieces of the leaflet in patient¿s left ventricle." the following additional information was requested, answers in quotes: -was this aortic valve implanted into the mitral position? "no, the on-x aortic valve was implanted in aortic position." -can you clarify at what point during the procedure the valve was discovered to have a missing leaflet? "dr.Said 'it was aortic view, superior position.'" -before suturing in, after, etc? "the valve has been implanted completely so it was after suturing." -did any metal surgical instruments come in contact with the leaflets? "no" -was leaflet function tested with the provided leaflet probe in the instrument kit? "yes, he always uses on-x leaflet probe." -what is the current patient status? "he is fine." "also this letter has been written by [the surgeon] which has expounded the details of the operation - 'a (b)(6) patient was a candid of mvr-avr-cabg [mitral valve replacement, aortic valve replacement, coronary artery bypass grafting].A st.Jude mitral valve was implanted and when the on-x valve was completely implanted, i noticed the absence of one of the leaflets.Therefore, the implanted valve was taken out immediately and we found the 2 un-even broken pieces of the leaflets in the lv [left ventricle].My viewing approach was from a superior position & aortic view and based on this approach we were able to emit the two pieces from the lv.'".

• Brand Name: ON-X AORTIC HEART VALVE WITH EXTENDED HOLDER 21MM
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e anderson ln.; 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: 6350192
• MDR Text Key: 68049392
• Report Number: 1649833-2017-00020
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXAE-21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/26/2017
• Date Manufacturer Received: 01/26/2017
• 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; Life Threatening; Required Intervention
• Patient Age: 72 YR