MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ AUSTIN ONX MITRAL STANDARD 27/29; HEART-VALVE, MECHANICAL

Model Number ONXM-27/29

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 01/02/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to initial reports, patient received onxm-27/29 sn (b)(4) (b)(6) 2020.Patient deceased (b)(6) 2020.

Manufacturer Narrative

According to initial reports, patient received onxm-27/29 sn (b)(6) 2020.Patient deceased (b)(6) 2020.Multiple attempts at additional information have gone unmet.The manufacturing records for the onxm-27/29 sn (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.Onxm-27/29, sn (b)(6), was implanted on (b)(6) 2020 in the mitral position in an 87-year-old female patient.While screening for participation in a clinical trial, the investigational site indicated the patient was deceased.An obituary was found online that indicated a date of death of (b)(6) 2020 (same day as the implant).The cause of death was not noted in the obituary.Multiple attempts were made to acquire additional information from the hospital; however, no response was received.Thus, we do not have a discharge summary nor any post-surgical information.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 to indicate what, if any, contribution the valve had to the death of the patient.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].No further action is warranted at this time.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): CRYOLIFE, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 9898457
• MDR Text Key: 185551996
• Report Number: 1649833-2020-00007
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/23/2023
• Device Model Number: ONXM-27/29
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/13/2020
• Date Manufacturer Received: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 87 YR