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

Model Number ONXMC-25/33

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 10/19/2016

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, "after implanting the on-x mitral valve with the conform x sewing ring, [the surgeon] noticed an ekg issue as the patient was ready to come off pump.[the surgeon] then performed a bypass of the circumflex artery.[the surgeon] feels that due to the patient's unique position of the circumflex artery, the sewing ring may have compressed the circumflex artery." patient impact reported as "after implanting the on-x mitral valve, [the surgeon] had to perform a cabg [coronary artery bypass grafting] which prolonged surgery additional 2+ hours.".

Manufacturer Narrative

The following additional information was requested from the rep: type of suturing technique employed, if implant operative notes are available, and current patient status.The rep provided the following update based on a meeting with the surgeon "the patient is doing fine and nothing else to report at this time.¿ 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 reported to have been implanted (b)(6) 2016, but an implant registration card has not been received by on-x device tracking to verify this.Surgeon opinion is that an abnormal ecg (electrocardiogram) at surgery suggested that placement of the valve in the mitral position compressed the circumflex artery which was in a "unique" anatomical position.The artery was bypassed, which added approximately two hours to the time of surgery.Subsequent follow-up visit (approximately three months postop) was conducted with the surgeon who reported that patient is ¿doing fine¿ and had nothing else to add.The "unique" patient anatomy made standard placement of the on-x conform-x mitral valve problematic.Normal suturing technique for this supra-annularly placed valve is thought to have compromised normal blood flow in the circumflex artery which was evidenced by an abnormal ecg at surgery.The anatomical anomaly was compensated for with a bypass that allowed for the resumption of normal blood flow.Although the bypass procedure added to the time of surgery, the outcome was successful and the patient is reported to be doing fine as of several months later.The case represents a technical solution to an abnormal anatomical situation.The root cause for the reported event is anatomical aberration requiring compensatory technical resolution to an otherwise normal mitral valve replacement.This event does not identify additional hazards or modify the probability and severity of existing hazards.

Event Description

According to the initial report, "after implanting the on-x mitral valve with the conform x sewing ring, [the surgeon] noticed an ekg issue as the patient was ready to come off pump.[the surgeon] then performed a bypass of the circumflex artery.[the surgeon] feels that due to the patient's unique position of the circumflex artery, the sewing ring may have compressed the circumflex artery." patient impact reported as "after implanting the on-x mitral valve, [the surgeon] had to perform a cabg [coronary artery bypass grafting] which prolonged surgery additional 2+ hours.".

• Brand Name: ON-X MITRAL HEART VALVE WITH CONFORM-X SEWING RING 25/33 MM
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln.; building 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: 6116577
• MDR Text Key: 60447512
• Report Number: 1649833-2016-00075
• 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
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/01/2022
• Device Model Number: ONXMC-25/33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/25/2016
• Date Manufacturer Received: 10/25/2016
• 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): Hospitalization