MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX ASCENDING AORTIC 23; HEART-VALVE, MECHANICAL

Model Number ONXAAP-23

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

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, implanted, post operatively scanned.Leaflet missing.Opened patient back up and leaflet was missing.

Manufacturer Narrative

The explanted valve was returned to on-x for evaluation.Prior to decontamination, visual examination of the valve found the left leaflet cracked into four (4) fragments.The right leaflet was still contained within the housing.After decontamination, visual examination did not note any chips or scratches in the housing around where the left leaflet attaches to the housing.Upon reassembly of the cracked left leaflet, it was noted that the cracks were found to be formed radially from a center point on the leaflet as opposed to typical high stress locations that would give due to wear and use.The remaining leaflet was found to articulate normally, the housing appeared normal, and no visual anomalies were found on either.Both the right leaflet and the housing were found to pass all inspections performed under the sample evaluation.The fractures appear to be caused by direct contact with an instrument.Sem scans of the part found iron elements which are common in surgical steel used in instrumentation.The fracture on the housing appears to be related to manipulation with metallic instrument, most likely at time of implantation.The damage to the leaflet cannot be determined from the sample evaluation, however if a metal instrument was used during implantation, it could have caused damage to the leaflet that lead to the eventual fracture of the leaflet.Manipulating the leaflet with a metal instrument during implantation could lead to a substrate fracture that would not be detectable with the naked eye.Continuous use of the valve could lead to a total fracture with time.The location of the fracture on the leaflet could have contributed to the dissociation of the leaflet from the housing.The manufacturing records for the onxaap-23 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.Leaflet escape, especially from an on-x valve, is extremely rare.Mechanism of leaflet fracture most likely due to direct contact with metal surgical instruments.The classification of this event is that of prosthesis structural dysfunction with consequent reoperation and explantation.All of these are recognized possible adverse events associated with prosthetic valve replacement [ifu].The on-x ascending aortic prosthesis (aap) 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.Device contact with metal instrument during surgery is root cause for leaflet escape.The onxaap-23 (sn#: (b)(6) implanted on (b)(6) 2019 was explanted after post-operative imaging showed one leaflet missing.Sample evaluation of the onxaap-23 and escaped leaflet pieces (4) using visual inspection and scanning electron microscopy (sem) determined that the leaflet had come into contact with a metal instrument which may have caused a substrate fracture not discernible to the naked eye.There was no alleged deficiency toward the original aap implant prior to the leaflet escape.On-x lti states the potential adverse effects of implantation of the aap device in the on-x aap instructions for use 7 of the aap ifu includes a caution statement against the use of metal instruments on the on-x valve and potential adverse effects if metal instruments are used, including leaflet escape.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 ASCENDING AORTIC 23
• 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: 8915149
• MDR Text Key: 155051966
• Report Number: 1649833-2019-00051
• 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: 01/16/2020

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: Health Professional
• Device Model Number: ONXAAP-23
• Device Catalogue Number: ONXAAP-23
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/22/2019
• Initial Date Manufacturer Received: 07/22/2019
• Initial Date FDA Received: 08/21/2019
• Supplement Dates Manufacturer Received: 07/22/2019
• Supplement Dates FDA Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR