MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC ON-X ASCENDING AORTIC PROSTHESIS 23MM; MECHANICAL VALVE CONDUIT

Model Number ONXAAP-23

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Complaint, Ill-Defined (2331); No Information (3190)

Event Date 07/03/2016

Event Type  Death  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the implant recovery card and the (b)(6) clinic's monthly reported list, patient implanted with onxaap-23 ((b)(4)) on (b)(6) 2016 and died on (b)(6) 2016.

Manufacturer Narrative

According to the implant registration cards (irc) from mayo clinic's monthly reported list, a patient was implanted with an ascending aortic prosthesis (onxaap-23, sn (b)(4)) on (b)(6) 2016 and died of unknown causes on (b)(6) 2016.Multiple attempts to obtain additional information were made without success.Phone calls placed on (b)(6) 2016 to hospital staff indicated that a written request for information would have to be made via fax to obtain patient information.The fax request was sent same day.A follow-up phone to the hospital on (b)(6) 2016 indicated that the request would be with the medical examiner and no additional information was available.A response back from the medical examiner was not received.If additional information becomes available, it will be evaluated and the complaint will be re-opened.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.According to the limited available information, the onxaap-23, sn (b)(4), was implanted on (b)(6) 2016 and the patient died (b)(6) 2016 (2 days postop).The death was noted on the irc and no other information was provided.Therefore, there is inadequate information available to ascertain what relationship, if any, the valve had to the death of the patient.The root cause is unknown.

Event Description

According to the implant recovery card and the (b)(6) clinic's monthly reported list, patient implanted with onxaap-23 ((b)(4)) on (b)(6) 2016 and died on (b)(6) 2016.

• Brand Name: ON-X ASCENDING AORTIC PROSTHESIS 23MM
• Type of Device: MECHANICAL VALVE CONDUIT
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC; 1300 e. anderson ln.; bldg b; austin TX 78752
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 5910763
• MDR Text Key: 53383791
• Report Number: 1649833-2016-00043
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXAAP-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2016
• 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): Death; Other