MAUDE Adverse Event Report: ON-X LIFE TECHONOLOGIES, INC ONX MITRAL CONFORM 25/33; HEART-VALVE, MECHANICAL

Model Number ONXMC-25/33

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 06/20/2017

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 email from a representative, "i am writing to report a phone call i just received from [medical center], please see below: [doctor] was implanting a [mechanical valve] today.When the valve was completed sewn into place one of the leaflets was stuck in place due to so tissue jamming up.The doctor try to free up the tissue so the leaflet would begin to move however the leaflet ended up breaking.The valve was then explanted and replaced with a different company valve." per the notification form provided, patient impact reported as "the surgical time had to be extended due to the need to remove the damaged valve and replace it with another.".

Manufacturer Narrative

A review of the valve housing and leaflet was performed.The microscopic visual examination of the housing for sn (b)(4), fracture surfaces of the broken leaflet, and review of the sem report from the third party vendor concluded the following: there is no evidence of metallic instrumentation contact however; there are chips on the datum b likely introduced by the instrument that was being used to ¿remove tissue¿ just prior to the time of the leaflet fracture.This is an overload fracture with its origin at the outflow side of the datum b.There is an abrasion on the housing id that could be a result of the broken leaflet being ejected at the time of the fracture or contact with instrument being used to ¿remove tissue¿ as stated in the initial report.The root cause of the leaflet fracture and escape was an iatrogenic overstress event that caused significant damage to the valve structural integrity.The manufacturing records for the onxmc-25/33, 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.No non-conformance or deviations were noted.No further action warranted.

Event Description

According to the initial email from a representative, "i am writing to report a phone call i just received from [medical center], please see below: [doctor] was implanting a [mechanical valve] today.When the valve was completed sewn into place one of the leaflets was stuck in place due to so tissue jamming up.The doctor try to free up the tissue so the leaflet would begin to move however the leaflet ended up breaking.The valve was then explanted and replaced with a different company valve." per the notification form provided, patient impact reported as "the surgical time had to be extended due to the need to remove the damaged valve and replace it with another.".

• Brand Name: ONX MITRAL CONFORM 25/33
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHONOLOGIES, INC; 1300 e. anderson ln.; bldg. b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES; 1300 e. anderson ln.; bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd nw; kennesaw, GA 30144
• MDR Report Key: 6725049
• MDR Text Key: 80456510
• Report Number: 1649833-2017-00057
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXMC-25/33
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/20/2017
• Date Manufacturer Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention