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

Model Number ONXMC-25/33

Device Problem Perivalvular Leak (1457)

Patient Problems Heart Failure (2206); Regurgitation (2259)

Event Date 10/29/2018

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

Patient received onxmc-25/33 sn (b)(4) on (b)(6) 2012 with an explant on (b)(6) 2018.According to the operative notes, "the patient initially did well but recently has developed progressive congestive heart failure symptoms.The patient had a severe perivalvular leak around her mechanical valve on transesophageal echocardiography.Percutaneous attempts were unsuccessful in closing this leak.The patient was referred for closure of perivalvular leak, possible redo mitral valve replacement.".

Manufacturer Narrative

The explanted valve was not returned, therefore, no direct observation could be made.The manufacturing records for onxmc-25/33 sn [serial number] (b)(4) were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications.All lots passed functional testing and met release specifications.60.24 year old female patient implanted with onxmc-25/33, sn (b)(4) , in (b)(6)2012 with concomitant maze procedure and required explant/replacement in (b)(6)2018 due to congestive heart failure, severe mitral regurgitation secondary to pvl [paravalvular leak], as well as severe tricuspid regurgitation.Echo confirmed 2 areas of leak and per the operative notes, prior percutaneous attempts to close the leak were unsuccessful.Patient medical history significant for chronic renal insufficiency.The relevant event for this complaint is severe paravalvular leak as a consequence of separation of the valve from the annular tissue resulting in severe mitral regurgitation and subsequent decreased cardiac output and congestive heart falure necessitating explantation and replacement of the mitral prosthesis.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 1.2%/patient-year and major pvl of 0.6%/patient-year [iso 5840:2005].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 [mcnicholas 2006].Another study of 117 mitral on-x patients reported 5 late pvls, of which 2 were major [palatianos 2007].The root cause of the pvl cannot be determined based on the available information.However, there is no indication that the on-x valve itself failed to function or perform as designed.No further action is required at this time.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

Patient received onxmc-25/33 sn (b)(4) on (b)(6)2012 with an explant on (b)(6)2018.According to the operative notes, "the patient initially did well but recently has developed progressive congestive heart failure symptoms.The patient had a severe perivavlular leak around her mechanical valve on transesophageal echocardiography.Percutaneous attempts were unsuccessful in closing this leak.The patient was referred for closure of perivavlular leak, possible redo mitral 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: 8196360
• MDR Text Key: 131404232
• Report Number: 1649833-2018-00181
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2017
• Device Model Number: ONXMC-25/33
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/27/2018
• Date Manufacturer Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 60 YR