MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL PROSTHETIC VALVE; HEART-VALVE, MECHANICAL

Model Number ONXMC-25/33

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

Patient Problems Congestive Heart Failure (1783); Endocarditis (1834); Regurgitation, Valvular (2335)

Event Date 04/11/2018

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 and implant registration card, size 25/33 onxmc, mitral heart valve with conform-x sewing ring, serial number (b)(4), was previously implanted on (b)(6) 2015 then replaced with 25/33 onxmc, serial number (b)(4) on (b)(6) 2018 due to undisclosed reasons.Additional information was received via operative notes.According to the operative notes, ¿the patient is a (b)(6) male with a complicated past medical history.He originally developed endocarditis, underwent avr and mitral valve repair in 2010.In 2015, he underwent a redo mitral valve replacement with a mechanical valve implanted for severe mitral stenosis via right thoracotomy.Most recently, he developed end-stage renal disease and underwent renal transplantation in (b)(6) 2017.¿over the last 1-1/2 months, he has developed worsening failure of his transplanted kidney requiring re-initiation of dialysis.He developed a perinephric hematoma which was infected and drained.He also was diagnosed with endocarditis and had developed a new severe perivalvular leak around the mitral valve causing congestive heart failure with pulmonary hypertension.¿.

Manufacturer Narrative

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.A review of the available information was performed.The on-x valve was implanted on (b)(6) 2015 in the mitral position of a 24 year old male.Following a diagnosis of paravalvular leak (pvl) resulting in congestive heart failure (chf), this valve was explanted and replaced on (b)(6) 2018 (2 years 278 days post-implant) with onxmc-25/33 sn: (b)(4).This patient also had a size 21 on-x aortic heart valve with conform-x sewing ring with extended holder, onxace-21, sn: (b)(4) implanted on (b)(6) 2010 (plus mitral repair), which was not replaced, so this is a double prosthetic valve replacement patient.He has end stage renal disease on dialysis, renal transplantation 12/2017 which worsened putting him back on dialysis, severe posterior mitral annular calcification, history of endocarditis, and lupus.The relevant event for this complaint is severe paravalvular leak (pvl) as a consequence of separation of the valve from the annular tissue ultimately resulting in explantation and replacement of the mitral prosthesis.The location of the leak is adjacent to the aortic valve.With the complicated history and surgery of the patient, this region has been subject to infection and under constant manipulation.Its integrity is likely compromised even though no infection was noted during the most recent reoperation.In addition to the mitral valve replacement, the tricuspid valve was repaired due to moderate to severe regurgitation.Pvl is a rare but known risk for mitral valve replacement surgery, as is explantation.Both are listed as potential complications in the on-x valve instructions for use.Objective performance criterion report a rate of all pvl of (b)(4)/ patient-year and major pvl of (b)(4)/ patient-year.In clinical trials, late (30 days) occurrences of 1 major and 2 minor pvls were observed in a study of 142 mitral on-x patients [(b)(6) 2006].Another study of 117 mitral on-x patients reported 5 late pvls of which 2 were major [(b)(6) 2007].There is no indication that the on-x valve itself failed to function or perform as designed.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 and implant registration card, size 25/33 onxmc, mitral heart valve with conform-x sewing ring, serial number: (b)(4), was previously implanted on (b)(6) 2015 then replaced with 25/33 onxmc, serial number: (b)(4) on (b)(6) 2018 due to undisclosed reasons.Additional information was received via operative notes.According to the operative notes, ¿the patient is a 26-year old male with a complicated past medical history.He originally developed endocarditis, underwent avr and mitral valve repair in 2010.In 2015, he underwent a redo mitral valve replacement with a mechanical valve implanted for severe mitral stenosis via right thoracotomy.Most recently, he developed end-stage renal disease and underwent renal transplantation in 12/2017.¿over the last 1-1/2 months, he has developed worsening failure of his transplanted kidney requiring re-initiation of dialysis.He developed a perinephric hematoma which was infected and drained.He also was diagnosed with endocarditis and had developed a new severe perivalvular leak around the mitral valve causing congestive heart failure with pulmonary hypertension.¿.

• Brand Name: ONX MITRAL PROSTHETIC VALVE
• 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: 7635510
• MDR Text Key: 112277826
• Report Number: 1649833-2018-00123
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXMC-25/33
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/31/2018
• Date Manufacturer Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 26 YR