MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ AUSTIN ONX AORTIC STANDARD EXT 23; HEART-VALVE, MECHANICAL

Model Number ONXAE-23

Device Problem Insufficient Information (3190)

Patient Problem Insufficiency, Valvular (1926)

Event Date 01/16/2020

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, user facility sent an implant notification for onxae-23 sn (b)(4) with a notation the valve had been implanted (b)(6) 2020 and explanted (b)(6) 2020.The surgeon's office was contacted.According to surgical notes, the valve was explanted due to pvl.The current status of the patient is "discharged".The staff nurse could not tell me if there was a deficiency with the valve.No additional information is forthcoming.This investigation is relegation to onxae-23 sn (b)(4).

Manufacturer Narrative

Notification was received from the user facility for onxae-23 sn (b)(6).According to initial reports, the product implant form came back with a notation that the valve had been implanted (b)(6) 2020 and explanted (b)(6) 2020.Additional information was received from.Surgical notes stated the valve was explanted due to pvl.The current status of the patient is "discharged".No additional information is forthcoming.The manufacturing records for the onxae-23 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.Onxae-23 sn (b)(6) was implanted (b)(6) 2020 in the aortic position of a 62-year-old male.On (b)(6) 2020 (7 days post implant), this valve was reported as explanted.No other information was provided including whether or not the valve was replaced nor the status of the patient.There is not enough information to know why the decision was made to explant the original on-x valve and, therefore, we have no evidence to suggest what, if any, contribution the original valve made to it.The instructions for use [ifu] for the on-x valve acknowledge reoperation and explantation as potential consequences of a complication following prosthetic valve replacement, but we have no evidence of any valvular malfunction.There is too little information to determine what, if any, relationship the valve has to the decision to explant it.Root cause for this event is unknown.No further action is required without additional information.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 STANDARD EXT 23
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): CRYOLIFE, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 9818851
• MDR Text Key: 183564464
• Report Number: 1649833-2020-00002
• 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: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXAE-23
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/27/2020
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR