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

Model Number ONXANE-23

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Pannus (1447); Aneurysm (1708); Aortic Valve Stenosis (1717)

Event Date 02/24/2020

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, implant registration card for onxaap-27/29 sn (b)(4), implanted (b)(6) 2020, received back from the user facility for a patient with an existing valve (onxane-23 sn (b)(4)) implanted (b)(6) 2010.This investigation is relegated to onxace-23 sn (b)(4).Operative notes received."¿redo sternotomy without injury.His prior aortic valve had dehisced along the aorto-mitral curtain, and he also had an aorta-ventricular dehiscence along this length.This area was smooth walled and no vegetation or active signs of infection.However, once we removed the valve under the right coronary cusp, where we had previously patched his annular defect with bovine pericardium, there was some shaggy pannus that could represent old vegetation.".

Manufacturer Narrative

According to initial reports, the implant registration card for onxaap-27/29, sn: (b)(6), implanted on (b)(6) 2020, was received back from the user facility for a patient with an existing valve (onxane-23, sn: (b)(6) implanted on (b)(6) 2010.This investigation is relegated to onxace-23, sn: (b)(6).The manufacturing records for the onxace-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.The patient was implanted on (b)(6) 2019 with an onxane-23, sn: (b)(6) in the aortic position of a 41-year-old male who is registered in the on-x post approval study.An onxaap-27/29, sn: (b)(6) was implanted on (b)(6) 2020 (286 days post-implant).The preoperative diagnosis includes "severe symptomatic aortic stenosis, aortic root aneurysm, ascending aortic aneurysm, and bicuspid aortic valve.¿ the patient's aortic root replacement operative note was made available which noted that 'his prior aortic valve had dehisced along the aorto-mitral curtain, and he also had an aorto-ventricular dehiscence along this length.This area was smooth walled and no vegetation or active signs of infection.However.Once we removed the valve under the right coronary cusp, where we had previously patched his annular defect with bovine pericardium.There was some shaggy pannus that could represent old vegetation.We removed all this and sent for culture.We also removed all of the old bovine pericardia! patch.Due to his aorto-ventricular dehiscence we elected to perform a full root replacement.His valve was well seated on tee post op with normal washing jets.A report for the culture was not obtained.The patient was transferred to the intensive care unit in stable condition, intubated, on mild inotropic support.A subsequent communication indicated the patient was diagnosed with endocarditis of unknown etiology.Due to the patient's conditions, the aap was warranted.While the operative report indicates a successful surgery, we do not have a discharge summary; consequently, we do not know whether the patient was ever discharged from the hospital.In addition, it is unlikely the on-x valve was the source of the infection as on-x valves undergo a validated terminal sterilization procedure during manufacturing.The deterioration of the previous bovine pericardia! patch, the dehiscence of the valve.And the presence of the shaggy pannus strongly suggest the deleterious effects of infection, i.E.Endocarditis.Barring the dehiscence, there is no evidence to indicate any mechanical failure of the valve to perform as expected.However.This would be classified as prosthetic valve dysfunction due to endocarditis.The instructions for use for the on-x valve lists endocarditis as a possible complication of mechanical heart valve replacement and includes the possibility of reoperation and/or explantation [ifu].Historically, endocarditis occurs at a rate of 1.2 % / patient-year for rigid heart valves [iso 5840:2005).There is no indication that the explanted valve exhibited any deficiency of mechanical function.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 ANATOMIC 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: 9865377
• MDR Text Key: 191404441
• Report Number: 1649833-2020-00005
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 04/08/2020

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 Model Number: ONXANE-23
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/13/2020
• Initial Date Manufacturer Received: 03/13/2020
• Initial Date FDA Received: 03/23/2020
• Supplement Dates Manufacturer Received: 03/13/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR