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 Death (1802)

Event Date 01/08/2020

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, "clinical email for proact trial subjects listed this patient as deceased." patient received onxmc-25/33, serial number (b)(4) on (b)(6) 2019 and obituary confirmed death date of (b)(6) 2020.According to her obituary, she passed away "due to complications of major heart surgery.".

Manufacturer Narrative

The manufacturing records for onxmc-25/33, 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.During the investigation no non-conformances or deviations were noted.The onxmc-25/33, sn (b)(6) was implanted on (b)(6) 2019 in the mitral position in a 62-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 (30 days post-implant) due to ¿complications of major heart surgery.¿ the implantation operative report was made available.The patient was morbidly obese, had coronary artery disease (requiring a concomitant coronary artery bypass graft), and congestive heart failure (chf).In addition, the patient had comorbidities of cirrhosis and diabetes.The surgery was described as ¿extremely complex¿ taking almost 8 hours to complete due to the obesity and difficult anatomy as well as severe calcification around the mitral annulus.It took over 2 hours to obtain hemostasis because of a diffuse coagulopathy.Nevertheless, following implantation, the valve was described by transesophageal echocardiogram (tee) as working well with no paravalvular leak and both leaflets freely mobile.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 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.There is insufficient information to indicate a root cause for death of this on-x patient.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: 9652958
• MDR Text Key: 177154158
• Report Number: 1649833-2020-00084
• 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: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ONXMC-25/33
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 62 YR