MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC ON-X MITRAL HEART VALVE WITH CONFORM-X SEWING RING 25/33MM; MECHANICAL HEART VALVE

Model Number ONXMC-25/33

Device Problem Insufficient Information (3190)

Patient Problems Complaint, Ill-Defined (2331); No Information (3190); No Code Available (3191)

Event Date 01/15/2016

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 implant recovery card, patient implanted with onxmc-25/33 ((b)(4)) on (b)(6) 2015 which was explanted on (b)(6) 2016 and replaced with another onxmc-25/33.Additional information is pending.

Manufacturer Narrative

According to the implant registration card (irc) a patient implanted with an on-x mitral heart valve and conform-x sewing ring (onxmc-25/33, sn (b)(4)) on (b)(6) 2015 which was explanted on (b)(6) 2016 and replaced with another onxmc-25/33.Attempts to obtain additional clarifying information were unsuccessful.A phone call was made to the hospital on 10/12/2016 without success in obtaining information but on 10/13/2016 it was indicated by staff that no information would be released for the patient.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.All lots passed functional testing and met release specifications.During the investigation no non-conformances or deviations were noted.The onxmc-25/33, sn (b)(4), was implanted (b)(6) 2015 in the mitral position via mvr and required explant (28 post-op) on (b)(6) 2016 and replacement by another onxmc-25/33.There is insufficient information available to ascertain what, if any, relationship the explantation had to the valve.Reoperation and explantation are known risks of prosthetic heart valves of any brand and are not unique to the on-x valve.Both events are listed in the potential adverse events section found in the onxmc instructions for use (ifu).

Event Description

According to the implant recovery card, patient implanted with onxmc-25/33 ((b)(4)) on (b)(6) 2015 which was explanted on (b)(6) 2016 and replaced with another onxmc-25/33.Additional information is pending.

• Brand Name: ON-X MITRAL HEART VALVE WITH CONFORM-X SEWING RING 25/33MM
• Type of Device: MECHANICAL HEART VALVE
• 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 ; 7704193355
• MDR Report Key: 5910499
• MDR Text Key: 53371922
• Report Number: 1649833-2016-00039
• 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: 11/03/2016

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 Expiration Date: 02/14/2019
• Device Model Number: ONXMC-25/33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2016
• 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): Hospitalization; Other
• Patient Age: 14 YR