MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES ON-X PROSTHETIC AORTIC VALVE WITH STANDARD SEWING RING WITH EXTENDED HOLDER 21; HEART-VALVE, MECHANICAL

Model Number ONXAC-21

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

Patient Problem Corneal Pannus (1447)

Event Date 07/06/2017

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: on-x valve was explanted due to pannus in-growth.The surgeon described a doughnut shaped in-growth that attached to the inlet flare.Surgeon mentioned the patient was a rather large person.21mm on-x valve was replaced with a 25mm valve.

Manufacturer Narrative

Alleged pannus formation resulted in explant approximately 12 years postop.The instructions for use (ifu) identify explantation as a risk factor due to adverse events including pannus [instructions for use].The frequency of occurrence for pannus is not established and has been reported for the on-x valve only anecdotally.The ifu provides instruction about the potential adverse events associated with the use of prosthetic heart valves which includes prosthesis pannus.The on-x heart valve risk management file thoroughly identifies the process and product hazards for approved indications.Each individual hazard is mitigated and reduced as low as possible by design and process.Postproduction residual risk is communicated in the product's labeling and ifu.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: on-x valve was explanted due to pannus in-growth.The surgeon described a doughnut shaped in-growth that attached to the inlet flare.Surgeon mentioned the patient was a rather large person.21mm on-x valve was replaced with a 25mm valve.

Manufacturer Narrative

Alleged pannus formation resulted in explant approximately 12 years postop.The valve was not returned; however, pictures were provided.One shot appears to be of the valve just prior to explant; however, it is unclear if the pannus is present from the angle.There does appear to be a white ring of unknown material on the inner orifice of the valve superior to the leaflets.The other shots appear to be a ring of pannus that has been removed from the valve.The instructions for use (ifu) identify explantation as a risk factor due to adverse events including pannus [instructions for use].The frequency of occurrence for pannus is not established and has been reported for the on-x valve only anecdotally.The manufacturing records for onxac-21, 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.The ifu provides instruction about the potential adverse events associated with the use of prosthetic heart valves which includes prosthesis pannus.The on-x heart valve risk management file thoroughly identifies the process and product hazards for approved indications.Each individual hazard is mitigated and reduced as low as possible by design and process.Post-production residual risk is communicated in the product's labeling and ifu.This event does not identify additional hazards or modify the probability and severity of existing hazards.The root cause of the alleged pannus cannot be determined based upon available information.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: ON-X PROSTHETIC AORTIC VALVE WITH STANDARD SEWING RING WITH EXTENDED HOLDER 21
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES; 1300 e. anderson ln., bldg.b; austin TX 78752
• MDR Report Key: 8992439
• MDR Text Key: 161391812
• Report Number: 1649833-2019-00054
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ONXAC-21
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/11/2019
• Date Manufacturer Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 34 YR