MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL CONFORM 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 Death (1802); Regurgitation, Valvular (2335)

Event Date 04/29/2020

Event Type  Death  

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 received via email on 24-aug-2020, "a patient receiving two mvr procedures both with onxmc25/33 during the period (b)(6) 2019 to (b)(6) 2020 owing to serious regurgitation and perivalvar leakage respectively.Patient died due to kidney failure and other complications on (b)(6) 2020.Medical background: severe aortic root and aortic problems,previous surgery of aortic replacement and lower aortic stent implantation.Severe mitral valve and tricuspid valve regurgitation.This is also the reason for hospitalization on (b)(6) 2019 for mvr.Besides, patient has high blood pressure.Additional information received relayed that on 17-jan-2019 an onxmc 25/33 serial number: unknown was implanted in the patient.Then on (b)(6) 2020 the doctor employed interventional occlusion method (implanted vsd and pda) to block the perivalvular leak.The hospital patient discharge report mentioned that the occlusion was successful, perivalvular leakage disappeared.Then on (b)(6) 2020 the original onxmc 25/33 was explanted and occlude operation was performed, followed by implantation of a new onxmc25/33 (sn: (b)(4)).The patient was hospitalized during the period of (b)(6) 2020 to (b)(6) 2020.From the medical record written on (b)(6) 2019, this patient undergo ¿aortic root valvuloplasty + total arch replacement of ascending aorta + descending aorta stent implantation¿ two years ago.No record description about aortic valve replacement.

Manufacturer Narrative

The manufacturing records for onxmc 25/33 serial number: (b)(6) was reviewed.The review of the device history record was acceptable with the final product meeting all specifications.No serial number was provided for the other onxmc 25/33 valve.Sometime around early 2017 a 42-year-old male (date of birth on 1974) with high blood pressure received an aortic root valvuloplasty + total arch replacement of ascending aorta + a stent implantation in the descending aorta.Because of severe mitral valve regurgitation, on (b)(6) 2019, the patient received a mitral valve replacement with an on-x mitral valve prosthesis (onxmc-25/33 unknown serial number).The patient also had severe tricuspid regurgitation but no mention is made how that was addressed.The patient was later diagnosed with paravalvular leak (pvl) which resulted in an operation on (b)(6) 2020 in which the ¿doctor employed interventional occlusion method (implanted vsd and pda) to block the perivalvular leak.¿ the definitions for the acronyms vsd and pda were not provided.In any case, patient discharge report stated the pvl was successfully occluded and had disappeared.However, three days later (on (b)(6) 2020) the patient underwent a mitral valve redo operation in which the original on-x valve was replaced by a second, onxmc-25/33 sn: (b)(6).No reason is given for this replacement, but the patient appears to have died on the same day.The cause of death was attributed to ¿kidney failure and other complications.¿ paravalvular leak is the probable reason for the attempted redo operation on (b)(6)2020, but the cause of the paravalvular leak is unknown.It is also unknown how the attempted repair three days prior, deemed successful, may or may not have contributed to the decision to replace.There is even less evidence to suggest what contribution the paravalvular leak had to the death of this patient who appears to have had multiple comorbidities, dying of ¿kidney failure and other complications.¿ in summary, paravalvular leak is the probable reason for the redo operation, but because we don¿t have any further description, there is no evidence to indicate what, if any, contribution the on-x valve had to the cause of the pvl.Furthermore, there is no evidence to implicate the on-x valve in the death of the patient.Paravalvular leak is the probable cause necessitating explantation of the original on-x mitral valve, but there is otherwise no evidence to suggest that the on-x valve itself failed to perform as designed and manufactured.A review of the device history record (dhr) found that the valve met all specifications and testing requirements.There were no issues found in the manufacture of the device.The patient discharge report states cause of death as ¿kidney failure and other complications.¿ the patient received a mitral valve prosthesis on (b)(6) 2019.The patient was later diagnosed with paravalvular leak (pvl) on (b)(6) 2020 that was successfully occluded and had disappeared according to the patient discharge record.Three days later the patient underwent a mitral valve redo operation.No reason is given for the replacement.The clinical medical report stated pvl is the probable cause for the redo operation but the cause of the pvl is unknown.Because we don¿t have any further description, there is no evidence to indicate what, if any, contribution the on-x valve had to cause the pvl.There is no evidence to implicate the on-x valve in the death of the patient.The instructions for use for the on-x valve acknowledge pvl as a complication that may lead to reoperation and explantation, even death (ifu).The ifu provides instruction about the potential adverse events associated with the use of prosthetic heart valves which may lead to explantation and re-operation.The on-x heart valve risk management file thoroughly identifies the process and product hazards for approved indications.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.No action necessary.This event does not identify additional hazards or modify the probability and severity of existing hazards.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 cryolife is accurate or has been confirmed by cryolife.

Event Description

According to the initial report received via email on 24-aug-2020, "a patient receiving two mvr procedures both with onxmc25/33 during the period on (b)(6) 2019 to on (b)(6) 2020 owing to serious regurgitation and perivalvar leakage respectively.Patient died due to kidney failure and other complications on (b)(6) 2020.Medical background: severe aortic root and aortic problems, previous surgery of aortic replacement and lower aortic stent implantation.Severe mitral valve and tricuspid valve regurgitation.This is also the reason for hospitalization on (b)(6) 2019 for mvr.Besides, patient has high blood pressure.Additional information received relayed that on (b)(6) 2019 an onxmc 25/33 serial number: unknown was implanted in the patient.Then on (b)(6) 2020 the doctor employed interventional occlusion method (implanted vsd and pda) to block the perivalvular leak.The hospital patient discharge report mentioned that the occlusion was successful, perivalvular leakage disappeared.Then on (b)(6) 2020 the original onxmc 25/33 was explanted and occlude operation was performed, followed by implantation of a new onxmc25/33 (sn: (b)(6).The patient was hospitalized during the period of on (b)(6) 2020.From the medical record written on (b)(6) 2019, this patient undergo ¿aortic root valvuloplasty + total arch replacement of ascending aorta + descending aorta stent implantation¿ two years ago.No record description about aortic valve replacement.

• 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
• MDR Report Key: 10459179
• MDR Text Key: 204531658
• Report Number: 1649833-2020-00033
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P0000137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXMC 25/33
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 45 YR