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

Model Number ONXACE-27/29

Device Problem Insufficient Information (3190)

Patient Problem Atrial Fibrillation (1729)

Event Date 07/30/2020

Event Type  Injury  

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 hospitalized for atrial fibrillation.Cardioverted successfully.

Manufacturer Narrative

According to initial reports, patient presented to gp feeling tired and unwell.Permanent pacemaker (ppm) checked.Supraventricular tachycardia (svt) on ecg referred to impatient cardioversion and to remain on usual inr (2-3).Cardioversion (b)(6) 2020 successful.Additionally, the initial notification stated the event is device related.According to additional information received, the event is unrelated to the device.The information could not be confirmed either way, so in an abundance of caution an investigation will be performed for device onxace - 27/29 serial number (sn) (b)(6).The following additional information was received.Orientation of the valve could not be confirmed, etiology of the disease is congenital, patient experienced no previous cardiac surgery, no intra-operative adverse events, ejection fraction 55%, no ventricular aneurysm, no vascular pathology, no history of neurological events, no diabetes mellitus, hypertension, no high cholesterol, no known hypercoagulability, inr 2.5 (b)(6) 2019.The device remains implanted in the patient.The manufacturing records for the onxace - 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.Onxace-27/29 sn (b)(6) was implanted on (b)(6) 2019 in the aortic position of a 53-year-old male.On (b)(6) 2020 (308 days post-implant) the patient experienced an arrhythmia that required hospitalization and successful cardioversion.There is neither additional information nor evidence to indicate what, if any, contribution the valve made to the reported arrhythmia.Cardiac arrhythmia is a recognized potential adverse event associated with prosthetic valve replacement [ifu].This is a case of cardiac arrhythmia with no evidence of contribution by the on-x valve.No further action is required without further information.Based on the available information, root cause for this event is cardiac arrhythmia with no evidence of contribution by the on-x valve.Furthermore, there is no suggestion, evidence, or indication that the valve was functionally deficient.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 AORTIC CONFORM EXT 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: 10658880
• MDR Text Key: 210714106
• Report Number: 1649833-2020-00042
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXACE-27/29
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/29/2020
• Date Manufacturer Received: 09/29/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization