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

Model Number ONXM-27/29

Device Problem Perivalvular Leak (1457)

Patient Problems Mitral Regurgitation (1964); Respiratory Failure (2484)

Event Date 05/18/2018

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, onxm-27/29 sn (b)(4) was implanted on (b)(6) 2018 and required an explant on (b)(6) 2018.According to operative notes, "(b)(6) female status post urgent mitral valve replacement secondary to acute respiratory failure and acute mitral valve regurgitation requiring replacement of her mitral valve due to posterior tethering.The patient did well postoperatively but began to have acute shortness of breath and worsening symptoms at home and came to the emergency department where an echo revealed a large perivalvular leak.  echo concerning for perivalvular leak.  tee [transesophageal echocardiogram] done later during her admission revealed a more substantial leak and the patient was requiring transfusion decision made to take her to the operating room for emergent replacement of her mechanical mitral valve.".

Event Description

According to the initial report, onxm-27/29 sn (b)(4) was implanted on 04/24/2018 and required an explant on (b)(6)2018.According to operative notes, "43-year-old female status post urgent mitral valve replacement secondary to acute respiratory failure and acute mitral valve regurgitation requiring replacement of her mitral valve due to posterior tethering.The patient did well postoperatively but began to have acute shortness of breath and worsening symptoms at home and came to the emergency department where an echo revealed a large perivalvular leak.Echo concerning for perivalvular leak.Tee [transesophageal echocardiogram] done later during her admission revealed a more substantial leak and the patient was requiring transfusion decision made to take her to the operating room for emergent replacement of her mechanical mitral valve.".

Manufacturer Narrative

A review of the available information was performed.The manufacturing records for the onxm-27/29 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.The explanted valve was not returned, therefore a direct observation could not be made.Onxm-27/29 sn 6292807 implanted (b)(6)2018 in the mitral position of a 43 year old female; explanted and replaced (b)(6)2018 (24 days postop) by another on-x valve.The reoperative report was made available.Despite a positive discharge after the first implant, the patient ¿¿developed acute respiratory failure and acute mitral valve regurgitation requiring replacement of her mitral valve due to posterior tethering.¿ upon emergent reoperation, a small dehiscence was noted anteriorly and echocardiography confirmed the presence of a paravalvular leak [pvl].The original valve was removed and a new on-x valve of the same size and model was inserted in its place.Pledgeted sutures were placed with the large pledgets on the ventricular side, rather than the atrial side as last time.There were no immediate complications following this reoperation.The most likely cause of the pvl is a separation of the original valve from the mitral annulus.The condition of the annulus was not described, but because the suture pledgets were placed in the opposite direction from the previous operation suggests the difficult lay in making an adequate seal between the valve cuff and annulus tissue.There is no indication that the original on-x valve failed to function as designed.This was a case of ensuring a proper seating and seal.The instructions for use [ifu] notes the risk of paravalvular leak with subsequent reoperation and explantation as potential complications.The information provided suggests the paravalvular leak leading to reoperation and explantation/replacement is a consequence of inadequate sealing between the valve cuff and annulus tissue.The probable cause of the pvl is the suturing technique employed on the original valve although the condition of the annulus may be a contributing factor.There is no evidence that the on-x valve failed to function as designed.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.

• 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: 7624326
• MDR Text Key: 111834956
• Report Number: 1649833-2018-00120
• 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: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2023
• Device Model Number: ONXM-27/29
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/12/2018
• Date Manufacturer Received: 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR