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

Model Number ONXM-25

Device Problem Break (1069)

Patient Problems Dyspnea (1816); Hemoptysis (1887); Pulmonary Edema (2020); Tachycardia (2095); Unspecified Heart Problem (4454)

Event Type  Injury  

Event Description

According to the initial report, "[surgeon], cardiac surgeon at [hospital], removed an onxmc25/33 valve with a broken leaflet on a patient who arrived in emergency.She declared a serious incident on the valve.I saw the valve, and i confirm the reference and the leaflet broken.The first information comes from the pharmacist, [pharmacist].According to the first information at my disposal, the patient is (b)(6) and was operated six years ago in (b)(6).".

Manufacturer Narrative

This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to artivion is accurate or has been confirmed by artivion.Product code corrected to onxm-25.

Event Description

This patient was implanted in 2010 due to rheumatic valve disease.The patient has also benefited from an onxace 21 aortic prosthesis as well as a triscupid plasty.Long-term treatment: coumadine 4 mg 1/4 pill/day, enalapril 5 mg/day, oracillicine 1mu 2x/day; patient symptomatic during last visit with their cardiologist on (b)(6) 2022.Patient admitted to [hospital] for hemoptysis, dyspnea, and hypoxia (88%), cardiac frequency at 147 bpm.Severe pulmonary edema.A thoracic ultrasound showed a mitral prosthesis with a blade blocked in the open position, with no image of the second.Repatriation and transfer of the patient in medical reanimation at bichat hospital on 04/25/2022.Emergency replacement of mechanical mitral valve [another manufacturer] after exeresis of the onx prosthesis.Later, on (b)(6) 2022, vascular surgery to remove the blade broken in two, following migration to the aorto-iliac crossing.Surgical outcome requiring the installation of a right veno-arterial, femoro-axiliar ecmo.The patient is currently stabilized and was admitted to a recovery center.

Manufacturer Narrative

The valve was returned for evaluation.Prior to decontamination, visual examination of valve finds leaflet fractured in two pieces.The remaining leaflet was still contained within housing and sewing cuff intact.After decontamination, visual examination notes leaflet fracture along midline of leaflet with two chipped areas along top of leaflet near the fracture site.The remaining leaflet articulated normally in the pivot region and sewing cuff fit to housing appears normal.The pivot region where the fractured leaflet was appeared normal and there was no sign of wearing along the housing where the leaflet edge rests.The fracture appears to be caused by direct contact with an instrument.Sem scans of the regions found iron and chromium elements which are common in surgical steel used in instrumentation.The manufacturing records for onxm-25, serial number (b)(6) 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.On 10may2022 an complaint of a fractured leaflet was reported to artivion and an investigation was initiated on an onxm-25 with a serial number of (b)(6) that was implanted on (b)(6) 2016 in an approximately 11-year-old female in new zealand.Medical information provided for this report was provided by the explanting facility and surgeon in france.On (b)(6) 2016 onxm-25 with a serial number of (b)(6) was implanted in the mitral position due to rheumatic valve disease.In the notes provided it also states, ¿the patient has also benefited from an onxace 21 aortic prosthesis and was as a tricuspid plasty¿ and ¿ patient symptomatic during last visit with their cardiologist on (b)(6) 2022.¿ the order of events is as follows.On an unknown date the patient was ¿admitted to [hospital] for hemoptysis, dyspnea, and hypoxia (88%), cardiac frequency at 147 bpm.Severe pulmonary edema.A thoracic ultrasound showed a mitral prosthesis with a blade blocked in the open position, with no image of the second.Repatriation and transfer of the patient in the medical reanimation at [hosptial] on (b)(6) 2022.¿ then on (b)(6) 2022 the on-x valve was explanted and replaced with an [another manufacturer] 27mm valve, the surgeon declared it a serious incident on the valve and [doctor] reported it on 10may2022.Additional information was requested and received to include this follow-up information ¿ on (b)(6) 2022, (the patient had) vascular surgery to remove the blade broken in two, following migration to the artro-illac crossing.Surgical outcome requiring the installation of a right veno-arterial, femoro-axiliar ecmo.The patient is currently stabilized and was admitted to a recovery center.¿ device history record concluded that the valve passed on-x acceptance criteria prior to initial release.The returned valve underwent evaluation that included visual, microscopy, and sem microscopy by a consulting engineer.The manufacturer¿s quality engineer concluded that the leaflet fracture appears to be related to forces generated by contact and manipulation with metallic instruments.Sem scans of the regions found iron and chromium elements which are common in surgical steel used in instrumentation.Further, the evaluation found that the remaining leaflet articulated normally in the pivot region and sewing cuff fit to housing appears normal.The pivot region where the fractured leaflet was appeared normal and there was no sign of wearing along the housing where the leaflet edge rests.This is a case of prosthetic valve structural dysfunction which is listed as a potential complication in the instructions for use, as are the potential for reoperation and explantation [ifu].The on-x heart valve risk management file thoroughly identifies the process and product hazards for indication.Each individual hazard is mitigated and reduced as low as possible by design and process.Post production residual risk is communicated in the product¿s labeling and ifu.Based on the available information, the root cause appears to be related to forces generated by contact and manipulation with metallic instruments.The manufacturing records 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.This event does not identify additional hazards or modify the probability and severity of existing hazards.There is no indication that an error or deficiency occurred at artivion- formerly cryolife/jotec and the ifu adequately communicates risk.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to artivion is accurate or has been confirmed by artivion.

• Brand Name: ONX MITRAL CONFORM 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 ; 7704193355
• MDR Report Key: 14548081
• MDR Text Key: 292977753
• Report Number: 1649833-2022-00018
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001273
• UDI-Public: 851788001273
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/28/2020
• Device Model Number: ONXM-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2015
• 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): Other; Life Threatening