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

Model Number	ONXM-31/33
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Congestive Heart Failure (1783)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
Event or Problem Description
According to reports from the patient's wife, "they removed the mechanical valve and replaced it with a tissue valve." based on information obtained from a previous event, the explant was due to paravalvular leak.Please reference manufacturer report number 1649833-2018-00001 for previously reported event.
Event or Problem Description
According to reports from the patient's wife, "they removed the mechanical valve and replaced it with a tissue valve." based on information obtained from a previous event, the explant was due to paravalvular leak.Please reference manufacturer report number 1649833-2018-00001 for previously reported event.
Additional Manufacturer Narrative
The manufacturing records for the onxm-31/33 sn 6102906 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.Onxm-31/33 sn 6102906 reported as implanted(b)(6)2017 in the mitral position of a 70 year old male patient.Extensive medical records from (b)(6)2017 to (b)(6)2017 were made available.The patient has many medical issues including chronic kidney disease, diabetes mellitus, paroxysmal atrial fibrillation, hypertension, hyperlipidemia, coronary artery disease (with 4 stents placed).The patient had a pacer implanted in (b)(6)2017 for sick sinus syndrome.Complaining of shortness of breath, echocardiogram of (b)(6)2017 suggested mitral valve abnormality due to high gradients.Amiodarone was stopped on (b)(6)2017 due to concerns of toxicity.Fluoroscopy on (b)(6)2017 showed normally functioning prosthetic valve.Concern for congestive heart failure (chf) led to transesophageal echocardiogram on(b)(6)2017 which showed moderate to severe paravalvular leak (pvl) and a thrombus in the left atrium (patient had left atrial appendage ligation during mvr surgery).Consult of (b)(6)2017 for chf recommended another consult for (b)(6)2018 to consider a mitral plug if medical therapy fails.We did not receive any information about this proposed consult.Consequently, we are left with a probable paravalvular leak that has not yet been resolved.The reason for the pvl is unknown although a discussion of infection has not appeared in the dialog.Pvl is an uncommon but recognized risk of mitral valve replacement surgery.It is listed as a potential complication in the on-x valve instructions for use.Objective performance criteria report a historical rate for rigid prosthetic heart valves for all pvl of 1.2%/patient-year and major pvl of 0.6%/patient-year [iso 5840:2005].In clinical trials, late (>30 days) occurrences of 1 major and 2 minor pvls were observed in a study of 142 mitral on-x patients [mcnicholas 2006].Another study of 117 mitral on-x patients reported 5 late pvls, of which 2 were major [palatianos 2007].Cause of the leak is unknown at this time due to a lack of clinical information specifically addressing it.No further action is required at this time 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: ON-X PROSTHETIC MITRAL VALVE
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 7392990
• Report Number: 1649833-2018-00013
• Device Sequence Number: 11091492
• Product Code: LWQ
• UDI-Device Identifier: 00851788001297
• UDI-Public: 851788001297
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2018

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
• Operator of Device: Physician
• Device Model Number: ONXM-31/33
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/08/2018
• Initial Date Received by Manufacturer: 03/08/2018
• Supplement Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 04/03/2018
• Supplement Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 70 YR