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

Model Number ONXAAP-23

Device Problem Separation Failure (2547)

Patient Problem No Code Available (3191)

Event Date 02/18/2018

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, an onxaap would not detach from the holder when the button was pushed.As a result, surgery was "slightly prolonged.".

Manufacturer Narrative

The manufacturing records for the onxaap-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 sample review was performed (b)(6) 2018 for the onxaap-23 holder handle, sn (b)(4).The methods of evaluation were by visual, stereoscopic microscope and functional testing.The on-x aap holder handle material, components and assembly satisfied all applicable manufacturing specifications and quality requirements accordingly.Small markings from surgical instruments were found on the holder.According to the report, the physician encountered difficulty releasing the valve from its holder during surgery.Consequently, the surgery was "slightly prolonged".The holder handle was returned for evaluation with small markings from a surgical instrument.Manufacturing and inspection records showed that the holder handle had met all applicable quality requirements and performance specs accordingly.The retrieved aap holder handle was mechanically tested to mimic the resistance the physician described during surgery but no faulty mechanism was found.The holder handle was also disassembled to better examine under stereoscopic microscope the surface of each individual component but no physical anomalies were found.According to the ifu, ¿warning: do not attempt to re-insert the holder handle into the prosthesis (valve) once it has been released from the prosthesis.Doing so could damage the valve and cause catastrophic failure of the valve or harm to the patient." the investigation suggests that the only negative effect was a prolonged time while the surgical team or surgeon could not release valve from its holder.Based on the engineering evaluation a root cause of the aap holder handle mechanism malfunction during surgery could not be established because no manufacturing imperfections were found.No further action is warranted at this time.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 initial reports, an onxaap would not detach from the holder when the button was pushed.As a result, surgery was "slightly prolonged.".

• Brand Name: ON-X ASCENDING AORTIC PROSTHESIS
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austinaustin 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; kennesaw, GA 30144 ; 7703153355
• MDR Report Key: 7349331
• MDR Text Key: 102767986
• Report Number: 1649833-2018-00010
• 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,health
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/01/2019
• Device Model Number: ONXAAP-23
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/19/2018
• Date Manufacturer Received: 02/19/2018
• 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): Other