MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL STANDARD 27/29; HEART-VALVE, MECHANICAL

Model Number ONXM-27/29

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 12/06/2019

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 initial report, patient died on (b)(6) 2019.An obituary was found to confirm death date.This complaint is associated with onxm-27/29 sn (b)(4).

Event Description

According to the initial report,, patient died on (b)(4) 2019.An obituary was found to confirm death date.This complaint is associated with onxm-27/29 sn (b)(4).

Manufacturer Narrative

Multiple attempts to obtain additional information were made with no response.The manufacturing records for serial number (b)(6) 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.An onxm-27/29 sn (b)(6) was implanted on (b)(6) 2019 in the mitral position of a 69 year old male patient.While screening for participation in a clinical trial, the investigational site indicated this patient was deceased and therefore could not be enrolled in the study.An obituary was found online that indicated a date of death of (b)(6) 2019 (10 days post-implant) ¿¿ due to a complication that developed after heart surgery¿¿ that is all the information we have.The timing of the death (10 days postop) would tend to classify this as an operative mortality, although the cause is unknown.We do not have a discharge summary or any post-surgical information other than the obituary.Consequently, we do not know whether the patient was ever discharged from the hospital, nor do we have any post-operative diagnosis with the result that we have no evidence to indicate what, if any, contribution the valve had to this unfortunate clinical outcome.Although there is no evidence of valve involvement, the instructions for use (ifu) for the on-x valve lists death as a possible complication of mechanical heart valve replacement.Predictions of operative mortality after mitral valve replacement surgery show an operative mortality rate for males of 5.74% [edwards, 2001].If the patient had preoperative co-morbidities, the rate is increased, often substantially so.This event does not identify additional hazards or modify the probability and severity of existing hazards.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: ONX MITRAL STANDARD 27/29
• 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: 9659570
• MDR Text Key: 177398351
• Report Number: 1649833-2020-00085
• Device Sequence Number: 1
• Product Code: LWQ
• 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: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ONXM-27/29
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/15/2020
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 68 YR