MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ AUSTIN 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 Death (1802)

Event Date 02/28/2019

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 initial reports, patient enrolled in (b)(6) trial deceased.

Manufacturer Narrative

The manufacturing records for the onxmc-25/33 (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.A review of the available information was performed.An onxmc-25/33 sn (b)(6) was implanted on (b)(6) 2019 in the mitral position of a 63-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 (1-day post-implant) "following a period of declining health." that is all the information we have.The timing of the death (1 day 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.Multiple attempts for additional information have gone unmet.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 for the on-x valve lists death as a possible complication of mechanical heart valve replacement [ifu].Predictions of operative mortality after mitral valve replacement surgery show an operative mortality rate of (b)(4) [edwards, 2001].There is insufficient information to indicate a root cause for the death of this on-x patient.Without further information, no further action is required.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): CRYOLIFE, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 9671381
• MDR Text Key: 177804301
• Report Number: 1649833-2020-00087
• 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: study
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXMC-25/33
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/22/2020
• Date Manufacturer Received: 01/22/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 63 YR