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

Model Number ONXANE-21

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

Patient Problem No Code Available (3191)

Event Date 04/25/2018

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 initial reports, sales rep received a phone call from or circulator stating the onxane-21 did not fit into the patient.Surgeon said the grey sizer for 21mm fit prior to sutures and pledgets but could not get the valve to fit in the patient and was concerned about tearing the annulus.The surgeon said he would perform a root enlargement.The surgeon communicated (b)(6) 2018 the case went well.As the surgery was prolonged due to the root enlargement, this report is being submitted in an abundance of caution.

Event Description

According to initial reports, sales rep received a phone call from or circulator stating the onxane-21 did not fit into the patient.Surgeon said the grey sizer for 21mm fit prior to sutures and pledgets but could not get the valve to fit in the patient and was concerned about tearing the annulus.The surgeon said he would perform a root enlargement.The surgeon communicated(b)(6)2018 the case went well.As the surgery was prolonged due to the root enlargement, this report is being submitted in an abundance of caution.

Manufacturer Narrative

The manufacturing records for the onxane-21 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.A sample review was performed (b)(6)2018 for the onxane-21 sn (b)(4), by functional, dimensional, sem microscopy and visual evaluation.The visual under microscope and back lighting appear normal.No remarkable artifacts were present.The valve was evaluated through standard functional and dimensional inspections and was found to meet required functional ranges and dimensional specifications.No deficiencies are noted for this valve.A review of the available information was performed.According to the initial information, the surgeon stated the onxane-21 sn5736112 did not fit into the patient.The surgeon said the grey sizer for 21mm fit prior to sutures and pledgets but he could not get the valve to fit in the patient once the sutures were placed and was concerned about tearing the annulus.The surgeon performed a root enlargement and, according to the surgeon, the case went well.Inability to correctly size the annulus resulted in a root enlargement as the 21mm valve was the correct choice for this patient due to effective orifice area and body surface area guidelines.Onxl2 sizers are made with transparent "grey" colored plastic and are designed to be the same size as the corresponding heart valves.Grey sizers are intended for use after placement of sutures.In this case, the annulus was sized prior to suture placement which resulted in sizing discrepancy when attempting to place the valve.Additionally, evaluation of the returned valve indicated that it met all dimensional and functional specifications.Root cause for this event is surgeon sizing error - grey sizers are intended for use after suture placement which was not done in this case.Surgeon retraining is suggested.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 ANATOMIC SEWING RING WITH EXTENDED HOLDER
• 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: 7542593
• MDR Text Key: 109227994
• Report Number: 1649833-2018-00048
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXANE-21
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/25/2018
• Date Manufacturer Received: 04/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other