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

Model Number ONXM-27/29

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

Patient Problems Hemolytic Anemia (2279); No Code Available (3191)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

According to the distributor, "thru tee, valve regurgitation was recognized.Apparent leaflet constrained was not found.Annulus are in good shape.Sewing thread maybe loosening.The surgeon supposes that the event was not caused by failure of on-x valve." this investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the initial report, on-x mitral valve was explanted "but seemingly not caused by valve quality ".

Manufacturer Narrative

Additional information received: date of surgery: (b)(6) 2020 (redo); primary surgery: mvr on (b)(6) 2014; explanted valve: mitral 27/29, serial number (sn) (b)(6); cause of the event: valve dysfunction, hemolytic anemia; description of the event: thru tee, valve regurgitation was recognized.Apparent leaflet constrained was not found.Annulus are in good shape.Sewing thread maybe loosening.The surgeon supposes that the event was not caused by failure of on-x valve; patient: no infection was detected.The explanted valve was returned for further evaluation.Prior to decontamination, visual examination of valve found chips on the housing.After decontamination, the sewing cuff was cut to expose the serial number on the housing and it was determined that the part was in fact the onxm-27/29 (sn (b)(6)).Damage was observed on the housing, chip on the inflow and outflow edges.Leaflets move freely and the valve rotates as intended.The part was examined under magnification using a microscope and damage was noted on the housing.The part passed all inspection except visual inspection because of the damage to the housing and met all functional requirements and specifications.The complaint indicated that the part was returned because it was explanted, not related to a valve issue.Evaluation of the product found that the leaflets were both freely moving and the part passed all functional testing.Visual inspection found damage on the housing that is most likely related to damage during explantation.The manufacturing records for onxm-27/29 sn (b)(6) 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-27/29 sn (b)(6) was implanted (b)(6) 2014 in the mitral position of a patient of unknown age or gender.This valve was explanted (b)(6) 2020 (5 years 220 days post-implant).The explanted valve was provided to the manufacturer.Subsequent examination noted no functional abnormalities although the housing was damaged in a manner consistent with the explanting process.Processing records also show no abnormalities.The description provided is indicative of paravalvular leak (pvl).Since infection was ruled out and the annulus proclaimed in good shape, the focus is on the sutures keeping the valve in place.The surgeon¿s intimation that the sutures (¿sewing thread¿) may be loosening identifies the location of the problem, but does not provide the reason why they should be loosening.There are several possibilities, but all are speculative.Thus while we can comfortably assert the complaint to be paravalvular leak sufficient to warrant explantation (regurgitation and hemolytic anemia), we don¿t know enough about the integrity of the sutures to indicate its cause.We can only rule out endocarditis (infection).Loss of integrity of the sutures is the source of the paravalvular leak, but there is not enough information to sufficiently identify the exact cause for suture failure.However, none of the evidence presented indicates any contribution of the on-x valve to the loss of integrity.The instructions for use (ifu) for the on-x valve acknowledge paravalvular leak as a complication that may lead to reoperation and explantation.Major paravalvular leak occurs at a historical rate of 0.6%/valve-year for rigid heart valves and 1.2 %/valve-year for all pvl [iso 5840:2005].The event does not identify any 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, on-x mitral valve was explanted "but seemingly not caused by valve quality.".

• Brand Name: ON-X MITRAL VALVE UNKNOWN CONFIGURATION
• 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: 10337811
• MDR Text Key: 200810110
• Report Number: 1649833-2020-00025
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/25/2019
• Device Model Number: ONXM-27/29
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/01/2020
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/29/2020
• Supplement Dates Manufacturer Received: 07/01/2020
• Supplement Dates FDA Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other