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

Model Number ONXAE-23

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Aortic Regurgitation (1716); Embolism (1829)

Event Date 08/21/2016

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 report, "a cardiologist of patient reported a heart valve malfunction, and a severe ai was confirmed later by transesophageal echocardiogram.The results also showed an emboli formation.A redo surgery was performed and the mechanical heart valve was substituted.The explanted on-x valve is missing one leaflet and there is no trace of that one.".

Manufacturer Narrative

Multiple attempts were made for additional information, including whether the valve was available for return and analysis, pertinent patient comorbidities, historic record if inr preceding and at the time of the event, operative notes in english, details regarding the reported "emboli," and confirmation of the date of implant and date the "malfunction" and/or ai was discovered.The distributor provided the following response: "we have tried our very best to get [the surgeon's] cooperation in regards to the valve malfunction reported previously, but unfortunately we have not heard back from him yet despite of many follow ups." no further information is anticipated.The manufacturing records for the onxae-23, 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 review was performed of the available information.Onxae-23 sn (b)(4) presumed implanted (b)(6) 2016.Subsequently explanted (date not given) following indication of severe aortic insufficiency by transesophageal echocardiography (tee).Explanted valve showed missing leaflet which was not found in patient in whole or in part.All information is anecdotal.The reporting surgeon was uncooperative when additional information was requested.Therefore, no material, medical records, operative notes, etc.Are available for evaluation.Consequently, possible causes of the alleged detached valve leaflet cannot be effectively or adequately assessed.While the instructions for use mention the possibility of explantation due to a complication, they also describe the proper technique for handling and implanting the valve.Without additional information or material we cannot reasonably determine a potential relationship exists, if any, between the valve product (or surgeon) and the reported event.The root cause for the reported event is unknown; without additional information or material we cannot reasonably determine a potential relationship exists, if any, between the valve product (or surgeon) and the reported event.A review of manufacturing records indicates that the valve met specifications upon release.The ifu lists prosthesis thrombosis as a known potential risk associated with the use of the on-x valve.There is insufficient information to make a conclusion for the missing leaflet.

Event Description

According to the report, "a cardiologist of patient reported a heart valve malfunction, and a severe ai was confirmed later by transesophageal echocardiogram.The results also showed an emboli formation.A redo surgery was performed and the mechanical heart valve was substituted.The explanted on-x valve is missing one leaflet and there is no trace of that one.".

• Brand Name: ONX AORTIC STANDARD EXT 23
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144
• MDR Report Key: 6024146
• MDR Text Key: 57211966
• Report Number: 1649833-2016-00063
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/01/2020
• Device Model Number: ONXAE-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/13/2016
• Date Manufacturer Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other