MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL STANDARD 31/33; HEART-VALVE, MECHANICAL

Model Number ONXM-31/33

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

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

Event Date 10/06/2017

Event Type  Injury  

Manufacturer Narrative

A review of the available information was performed.The manufacturing records for the onxm-31/33 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.During the investigation no non-conformances or deviations were noted.This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the information received, a (b)(6) male received an onxm-31/33 ((b)(4)) on (b)(6) 2017 and required re-intervention/explant on (b)(6) 2017 due to severe large posterior dehiscence of prior mitral prosthesis.It was replaced with an onxmc-25/33 valve.

Manufacturer Narrative

A review of the available information was performed.The manufacturing records for the onxm-31/33 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.During the investigation no non-conformances or deviations were noted.Onxm-31/33 sn (b)(4) was implanted (b)(6) 2014 in the mitral position, explanted and replaced by onxmc-25/33 sn (b)(4) on (b)(6) 2017 (3 years 11 days post-implant) in a double valve procedure with onxae-23 sn (b)(4) in the aortic position.Minimal information was made available from an operative report that described the mitral replacement as ¿large posterior dehiscence of prior mitral prosthesis, posterior elements retained ¿ valve cultured, but no obvious vegetation or annular abscesses.¿ a dehiscence is indicative of a paravalvular leak (pvl), but we cannot tell from this report if the dehiscence is due to valve cuff failure (very rare) or tissue degeneration causing separation of the tissue from the sewing cuff (more common).We simply don¿t have enough information available to ascertain the nature or cause of the dehiscence and, consequently, cannot determine what, if any, relationship the valve has to the need for its replacement.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 criterior 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].Probable paravalvular leak of unknown origin of a mitral on-x prosthesis resulting in its explantation.And replacement.There is not enough information to determine what, if any, relationship the valve has to this outcome.This event does not identify additional hazards or modify the probability and severity of existing hazards.

Event Description

According to the information received, a (b)(6) male received an onxm-31/33 ((b)(4)) on (b)(6) 2017 and required re-intervention/explant on (b)(6) 2017 due to severe large posterior dehiscence of prior mitral prosthesis.It was replaced with an onxmc-25/33 valve.

• Brand Name: ONX MITRAL STANDARD 31/33
• 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: 7112188
• MDR Text Key: 94652992
• Report Number: 1649833-2017-00090
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001297
• UDI-Public: 851788001297
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2017
• Device Model Number: ONXM-31/33
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/17/2017
• Date Manufacturer Received: 11/17/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 57 YR