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

Model Number ONXANE-27/29

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Pannus (1447); Thrombus (2101)

Event Date 09/02/2020

Event Type  Injury  

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 experienced thrombus and pannus, which resulted in explant of valve (onxane-27/29 sn (b)(4)) on (b)(6) 2020.Date of implant of onxane: 27/29; sn (b)(4); (b)(6) 2016.Patient presented with evidence of leaflet malfunction of an on x anatomic valve that was implanted in 2016.Evidence showed via fluoroscopy and tte that one of the leaflets wasn't functioning properly.Surgery was scheduled to confirm as well as test for organisms, such as endocarditis.During the explanting case on 9.2.20, surgeon sent sample tissue before explantation to the lab, and it was confirmed that the samples show no organisms.The surgeon visually confirmed leaflet malfunction with an on x leaflet tester, and explanted the valve, along with all sutures and pledgets.He commented that a presence of thrombus was visible on the leaflet housing, and pannus was present on the inferior aspect of the valve, in and around the flared inlet.He also commented that thrombus was present on the sewing cuff, both around sutures and core knots.He also commented that the patient may not have been compliant with anti coagulation protocols.The surgeon later implanted the same size and type of on x anatomic mechanical valve.This investigation will be relegated to onxane-27/29 sn (b)(4).

Manufacturer Narrative

According to initial reports, patient experienced thrombus and pannus which resulted in explant of valve onxane-27/29 sn (b)(6).The following information was received.Patient presented with evidence of leaflet malfunction of an on-x anatomic valve that was implanted in 2016.Evidence showed via fluoroscopy and tte that one of the leaflets wasn't functioning properly.Surgery was scheduled to confirm as well as test for organisms, such as endocarditis.During the explanting case (b)(6) 2020, the surgeon sent sample tissue before explantation to the lab, and it was confirmed that the samples show no organisms.The surgeon visually confirmed leaflet malfunction with an on-x leaflet tester, and explanted the valve, along with all sutures and pledgets.He commented that a presence of thrombus was visible on the leaflet housing, and pannus was present on the inferior aspect of the valve, in and around the flared inlet.He also commented that thrombus was present on the sewing cuff, both around sutures and core knots.He also commented that the patient may not have been compliant with anticoagulation protocols.The surgeon implanted the same size and type of on-x valve as was the original valve.He only used non pledgeted, interrupted suture on the implanted valve.A visual, microscopy, functional review was performed on the returned valve.Prior to decontamination, visual examination of the valve found no damage.Leaflets move freely.After decontamination, the sewing cuff was cut to expose the serial number on the housing, and it was determined the part was in fact serial number (b)(6).The part was examined under magnification using a microscope and no visible damage was noted.The part was sent through full inspection.The part passed all inspections and met all requirements and specifications.The complaint could not be duplicated; therefore, no root cause could be assigned.The leaflets were both freely moving and passed all inspection and functional testing.No further action is required at this time.The manufacturing records for the onxane-27/29 sn (b)(6) were reviewed by quality assurance/quality control (qa/qc) 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.Onxane-27/29 sn (b)(6) was implanted (b)(6) 2016 in a 33-year-old male in the aortic position.This valve was explanted on (b)(6) 2020 (4 years 21 days post-implant) due to fluoroscopic and transthoracic echocardiogram results indicating that one of the leaflets was not functioning properly.Prior to explantation, the surgeon confirmed leaflet movement impairment and the valve was explanted in its entirety.The surgeon also observed the presence of thrombus visible on the leaflet housing and on the sewing cuff, both around the pledgeted sutures and cor-knots®.Pannus was noted around the inflow aspect of the valve, in and around the flared inlet.The explanting surgeon lastly noted that the patient may not have been compliant with anticoagulation protocols.A sample of tissue was sent to the hospital pathology lab which came back negative for infection.The valve was first sent to the hospital lab for testing and then returned to the manufacturer.As received by the manufacturer, there was no thrombus still attached to the valve and the leaflets moved freely.Functional analyses indicate that the valve passed all inspection criteria and met all requirements and specifications.Manufacturing records report no anomalies.Depending upon the size of the pannus, it may or may not have impeded the inflow orifice area.More concerning is the presence of thrombus, which is the likely source of the leaflet movement impairment.However, by the time the manufacturer received the explant, the thrombus could not be corroborated, nor the leaflet movement impairment replicated.With the information provided, this is likely a case of both aortic valve prosthesis pannus and thrombosis leading to prosthetic valve dysfunction.The thrombosis is likely a consequence of inadequate anticoagulation.The instructions for use for the on-x valve lists the possibility of prosthesis pannus, thrombosis, and valve dysfunction as potential complications associated with prosthetic valve replacement as well as reoperation and explantation [ifu].Thrombosis is a rare but known potential complication of prosthetic valve replacement occurring at a historical (b)(4) for rigid heart valves [iso 5840:2005e].Root cause for this event is thrombosis impeding leaflet motion as a probable consequence of inadequate anticoagulation compliance and, perhaps, a contribution of pannus overgrowth on the inflow aspect of the valve led to the decision to explant the on-x aortic valve.No further action is required.

• Brand Name: ONX AORTIC ANATOMIC 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: 10530880
• MDR Text Key: 214307600
• Report Number: 1649833-2020-00037
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXANE-27/29
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/02/2020
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR