MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC MITRAL VALVE WITH CONFORM-X SEWING RING; HEART-VALVE, MECHANICAL

Model Number ONXMC-25/33

Device Problem Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 04/26/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Implant registration card was received with "disposed" listed as the status.

Event Description

Implant registration card was received with "disposed" listed as the status.

Manufacturer Narrative

Corrected data: a2- age of patient updated.D6/d7- implant and explant dates entered.A review of the available information was performed.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.Onxmc-25/33, sn (b)(6) was implanted, presumably in the mitral position, in a 73-year-old male on (b)(6) 2019.The implant registration system reports that the valve was also ¿disposed¿ on the same day.No reason is given.The only correspondence received from the site states that the valve was being held in the local pathology lab at the request of the patient.There is no information to help us understand why the valve was implanted and explanted on the same day.Consequently, we have no way to know what, if any, relationship the valve had to the decision for its removal.The instructions for use for the on-x valve acknowledge explantation as a potential risk of prosthetic valve replacement [ifu].Without any information, we do not know what, if any, contribution the valve made to the decision to have it removed.No further action is required without additional information.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.

• Brand Name: ON-X PROSTHETIC MITRAL VALVE WITH CONFORM-X SEWING RING
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 8748443
• MDR Text Key: 149647021
• Report Number: 1649833-2019-00043
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001303
• UDI-Public: 00851788001303
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 12/13/2019
• Device Model Number: ONXMC-25/33
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 72 YR