MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC MITRAL VALVE WITH STANDARD SEWING RING; HEART VALVE MECHANICAL

Model Number ONXM-27/29

Device Problems Partial Blockage (1065); Insufficient Information (3190)

Patient Problems Endocarditis (1834); Mitral Regurgitation (1964)

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; on (b)(6) 2018 a (b)(6) year old male patient was considered for double valve replacement due to endocarditis.The first surgery was performed on (b)(6) 2018.On-x 27/29 mechanical valve prosthesis was implanted in the mitral position and sjm regent 25 mm was implanted in aortic position.The transesophageal echo (tee) in the operating room revealed good function of the aortic prosthesis and massive (3rd degree) central regurgitation of the mitral prosthesis due to insufficient leaflet closure.We decided to rotate the mitral valve prosthesis and put the patient on extracorporeal circulation (ecc) and arrested the heart again.The intraoperative test of the leaflet function was satisfying and we rotated the prosthesis by 90 degrees.The second test of the leaflet function was ok and the patient was weaned from the ecc.The new tee intraoperatively showed the same massive central regurgitation due to the insufficient leaflet closure.Due to the high mortality risk we did not consider a third cardioplegic arrest for this day and transferred the patient to the icu.Next day ((b)(6) 2018), during the doctors round, we performed a new tee and the result was the same - massive central mitral regurgitation.Then we decided to perform a third surgery and to explant the mitral valve prosthesis.According to the plan we explanted the on-x mitral prosthesis and implanted a new sjm 27 mm mechanical mitral valve prosthesis.The weaning from the ecc was unproblematic.The tee in the operating room showed excellent function of both sjm valve prosthesis.The postoperative stay was complicated with perioperative right-sided hepimaresis, dysarthria and temporary confusion.The patient recovered well during the hospital stay and was discharged from the hospital on (b)(6) 2018.

Event Description

According to initial reports; on (b)(6) 2018 a 61 year old male patient was considered for double valve replacement due to endocarditis.The first surgery was performed on (b)(6) 2018.On-x 27/29 mechanical valve prosthesis was implanted in the mitral position and sjm regent 25 mm was implanted in aortic position.The transesophageal echo (tee) in the or revealed good function of the aortic prosthesis and massive (3rd degree) central regurgitation of the mitral prosthesis due to insufficient leaflet closure.We decided to rotate the mitral valve prosthesis and put the patient on extracorporeal circulation (ecc) and arrested the heart again.The intraoperative test of the leaflet function was satisfying and we rotated the prosthesis by 90 degrees.The second test of the leaflet function was ok and the patient was weaned from the ecc.The new tee intraoperatively showed the same massive central regurgitation due to the insufficient leaflet closure.Due to the high mortality risk we did not consider a third cardioplegic arrest for this day and transferred the patient to the icu.Next day (b)(6) 2018 during the doctors round, we performed a new tee and the result was the same - massive central mitral regurgitation.Then we decided to perform a third surgery and to explant the mitral valve prosthesis.According to the plan we explanted the on-x mitral prosthesis and implanted a new sjm 27 mm mechanical mitral valve prosthesis.The weaning from the ecc was unproblematic.The tee in the or showed excellent function of both sjm valve prosthesis.The postoperative stay was complicated with perioperative right-sided hepimaresis, dysarthria and temporary confusion.The patient recovered well during the hospital stay and was discharged from the hospital on (b)(6) 2018.

Manufacturer Narrative

The manufacturing records for the onxm-27/29 sn (b)(4).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.During the investigation no non-conformances or deviations were noted.A sample review was performed for the onxm-27/29 sn (b)(4) by functional, dimensional, sem microscopy and visual evaluation.The valve was received and decontaminated for engineering investigation.The visual under microscope and back lighting appear normal.No remarkable artifacts present.The valve was evaluated through standard functional and dimensional inspections and was found to meet required functional ranges and dimensional specifications.No deficiencies are noted for this valve.The sample evaluation did not find any potential issues with the heart valve that may support the complaint of massive central mitral regurgitation due to insufficient leaflet closure.A review of the available information was performed.A 61 year old male patient underwent a double valve procedure on (b)(6) 2018 indicated for endocarditis and received st.Jude (sjm) regent 25mm aortic valves and onxm-27/29, sn (b)(4)in the mitral position.Per surgeon report, intraop transesophageal echocardiography (tee) revealed acceptable functioning of the aortic prosthesis and "massive (3rd degree) central regurgitation of the mitral prosthesis due to insufficient leaflet closure.¿ the surgeon indicated, 'we decided to rotate the mitral valve prosthesis and put the patient on extracorporeal circulation electrocardiogram (ecg) and arrested the heart again.The intraoperative (intraop) test of the leaflet function was satisfying and we rotated the prosthesis by 90 degrees.The second test of the leaflet function was ok and the patient was weaned from the ecc.The new tee intraoperatively showed the same massive central regurgitation due to the insufficient leaflet closure." due to potential risks, a third arrest was not attempted and the patient was transferred to icu.The following day tee revealed the same mitral regurgitation and the surgeon "decided to perform a third surgery and to explant the mitral valve prosthesis." the reference of a "third surgery" is interpreted to mean a third attempt to correct mitral valve function.The onxm-27/29 was explanted and an sjm was implanted.According to the report, "postoperative stay was complicated with perioperative right-sided hepimaresis (hemiparesis], dysarthria and temporary confusion.The patient recovered well during the hospital stay and was discharged from the hospital on (b)(6) 2018." the explanted valve was returned to on-x for evaluation and it was determined to meet all functional and dimensional specifications and no deficiencies were noted.Based on these findings alone, it is unlikely that the valve malfunctioned and is more likely associated with surgeon technique or an interference of native tissue e.G.Retained subvalvular mitral apparatus.Leaflet impingement by the native anatomy would therefore result in an apparent central regurgitation.Additionally, the instructions for use (ifu) suggests implanting the mitral valve in the anti-anatomic orientation.Whether or not this recommendation was followed, we do not know.Explant due to complication is listed in the ifu as a known potential complication.Although hemiparesis, dysarthria, and confusion (reported post-op) are often signs associated with stroke, this cannot be confirmed based on the available information.Furthermore, it was reported that the patient "recovered well" and was discharged on (b)(6) 2018.Based on the available information and returned valve evaluation, the reported events are unrelated to the valve and are instead likely associated with iatrogenic factors occurring during implant which resulted in leaflet impingement and subsequent regurgitation.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 PROSTHETIC MITRAL VALVE WITH STANDARD SEWING RING
• 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: 7328891
• MDR Text Key: 102325232
• Report Number: 1649833-2018-00007
• 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: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: ONXM-27/29
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/06/2018
• Distributor Facility Aware Date: 02/14/2018
• Date Manufacturer Received: 02/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 61 YR