MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ AUSTIN ON-X; HEART-VALVE, MECHANICAL

Model Number ONXACE-19

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Myocardial Infarction (1969)

Event Date 05/07/2020

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 initial reports, death certificate received; cause of death - probable myocardial infarction, coronary artery disease.Sig cond - hypertension, congestive heart failure, recent aortic heart valve replacement.This investigation relegated to onxace-19 sn (b)(4).

Manufacturer Narrative

According to a returned letter to the patient, the patient is deceased.The death certificate was provided notating cause of death ¿probable myocardial infarction.Coronary artery disease, hypertension; congestive heart failure; recent aortic heart valve replacement listed secondary.Attempts for additional information have gone unmet.The valve was not returned to the manufacturer for evaluation.This investigation is relegated to onxace-19 sn: (b)(6).The manufacturing records for the onxace-19 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.Onxace-19 sn: (b)(6) was implanted on (b)(6) 2019 in the aortic position of a 61-year-old female.A handwritten note from a presumed family member stated that the patient died in her sleep: "there were no indications that anything was wrong.She just didn't wake up." a copy of the death certificate was provided which states as a cause of death: "probable myocardial infarction.Coronary artery disease.Sig cond: hypertension; congestive heart failure; recent aortic heart valve replacement.¿ this event would be classified according to the guidelines as a cardiac death, not valve-related [akins 2008]: cardiac death includes all deaths resulting from cardiac causes.This category includes valve-related deaths, sudden unexplained deaths, and deaths from non-valve-related cardiac causes (eg, from heart failure, acute myocardial infarction, or documented arrhythmias).The date of death according to the death certificate was on (b)(6) 2020 (232 days post-implant).The evidence we have indicates that the death is attributable to myocardial infarction in a patient with coronary artery disease.There is no evidence that the on-x valve failed to perform as expected and intended.The instructions for use [ifu] for the on-x valve acknowledge death as a potential adverse event, but in this case, it is not valve-related.The root cause of the death is myocardial infarction in a patient with coronary artery disease.There is no evidence that the on-x valve contributed in any way to the heart failure.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.Field assurance will continue to monitor similar complaints to determine if additional actions are warranted; however, 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: ON-X
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): CRYOLIFE, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 11055552
• MDR Text Key: 223141434
• Report Number: 1649833-2020-00048
• 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: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/27/2023
• Device Model Number: ONXACE-19
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/09/2020
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 02/10/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 61 YR