MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X ASCENDING AORTIC PROSTHESIS; HEART, VALVE MECHANICAL

Model Number ONXAAP-23

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Bacterial Infection (1735)

Event Date 04/18/2018

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

An implant registration card was received for the same patient, same position, same valve product code, etc.Replacement sn (b)(4), onxaap 23 implanted (b)(4) 2018; onxaap 23, sn (b)(4) was implanted on (b)(6) 2018.The patient underwent reimplantation of a new 23 mm on-x and aortic root on (b)(6) 2018 due to a large left ventricular aneurysm and aortic root dehiscence possibly related to infection given the presence of purulent material.

Event Description

An implant registration card was received for the same patient, same position, same valve product code, etc.Replacement sn (b)(4) onxaap 23 implanted (b)(6)2018 ; onxaap sn (b)(4) was implanted on (b)(6)2018.The patient underwent reimplantation of a new 23mm onxaap on (b)(6)2018 due to a large left ventricular aneurysm and aortic root dehiscence possibly related to infection given the presence of purulent material.

Manufacturer Narrative

The manufacturing records for the onxaap-23, sn (b)(4) , were reviewed, and it was confirmed that all records were controlled, available for review and met all specifications.All lots passed functional testing and met release specifications.A review of the available information was performed.A 14 year old male patient received an onxaap-23, sn (b)(4) , on (b)(6)2018 indicated for aortic pseudoaneurysm which required explant subsequent replacement via onxaap-23 on (b)(6)2018 due to ¿large left ventricular aneurysm and aortic root dehiscence possibly related to infection given the presence of purulent material (on-x aortic valve culture grew coagulase negative staph sensitive to nafcillin.¿ surgery complicated by complete heart block requiring an epicardial pacemaker system.He was seen in follow up on (b)(6)2018 and echocardiogram at that time noted a small moderate pericardial effusion, normal biventricular systolic function, mild regurgitation.He remains on an antibiotic regimen at this time.¿ as stated by the hospital, intervention was required ¿possibly related to infection¿ which would explain the aneurysm and root dehiscence almost 3 months postop.Dehiscence in this case indicates that the valve cuff was separating from the aortic annular tissue.Separation of the cuff from the tissue is generally the result of deteriorating tissue due to infection.Pericardial effusion and conduction disturbances are also a common sequale of cardiac infection or endocarditis.Infection originating from an on-x valve product is highly unlikely as they are terminally sterilized.Listed in the instructions for use (ifu), operated valve endocarditis is a recognized risk of prosthetic valves that could lead to pseudoaneyrysm and dehiscence [akins 2008] as well as explanation [ifu].The objective performance criteria for rigid prosthetic valves indicates an endocarditis rate of 1.2%/patient-year.For reference, in the proact study for aortic valve replacement (avr), there were 9 reported cases out of 375 implants [pukas 2014].Root cause is infection, although definitive source is unknown.There is no indication that the infection is related to the on-x aap.No further action is required 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 ASCENDING AORTIC PROSTHESIS
• Type of Device: HEART, VALVE MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 7569002
• MDR Text Key: 110072058
• Report Number: 1649833-2018-00108
• 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
• Type of Report: Initial,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2020
• Device Model Number: ONXAAP-23
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/25/2018
• Date Manufacturer Received: 05/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 YR