MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC MITRAL VALVE 25MM; HEART-VALVE, MECHANICAL

Model Number ONXM-25

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

Patient Problems Embolism (1829); Multiple Organ Failure (3261)

Event Date 10/16/2017

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to an email forwarded on (b)(6) 2017: "dear [manufacturer representative] , we met [physician] some time back.He had 2 mitral valve patients who came back with a thrombosed and stuck valve.Both the patients were thrombolysed.One patient suffered stroke and could not survive.The second also suffered peripheral embolism and suffered organ faliure [failure] and could not survive.The first patient was admitted with an inr of 1.2 and the second patient with an inr of 1.9.This has led the doctor to percieve [perceive] that on-x is more thrombogenic in camparison [comparison] to other mechanical valves." this case is in reference to the second patient who passed due to organ failure.Another separate report has been submitted for the first patient.

Manufacturer Narrative

A review was held of all the available information.It was confirmed that all records were controlled, available for review, and met all specifications.All lots passed functional testing and met release specifications.During the investigation no non-conformances or deviations were noted.The valve was implanted on (b)(6) 2016.Patient died (b)(6) 2017 (1 year 41 days post-implant) of multiorgan failure including acute renal failure following thrombolysis therapy for ¿stuck valve¿, presumably due to thrombosis.Inr at the time of event was 1.9.Patient also diagnosed with atrial fibrillation.This patient¿s anticoagulation was sub-therapeutic.The inr guideline for mechanical prosthetic mitral valves is 2.5-3.5 with low dose of aspirin.An inr of 1.9 suggests the patient was out of compliance with the recommendations or difficulties may have occurred during clinical management of inr.Due to the lack of anticoagulation, a thrombus (clot) formed or lodged in the valve, creating the ¿stuck¿ description.The attempt to dissolve the clot resulted in release of pieces (thromboemboli) that floated to and lodged in the internal organs, particularly the kidneys leading to the death of the patient.Thrombosis, thromboembolism, and death are all recognized risk factors for mechanical mitral valve replacement cases [instructions for use (ifu)].Objective performance criteria report a historical thrombosis incidence of 0.8% per valve-year for all rigid prosthetic valves while the guidelines state that even with adequate anticoagulation the risk of thromboemboli is 1%-2% per year.Evidence suggests a sub-therapeutic anticoagulation causing formation of clot which embolised during attempted thrombolysis leading to a thromboembolic multi-organ failure, in particular the kidneys.These particular failures resulted in acute renal failure and subsequent death.The ifu lists prosthesis thrombosis as a known potential risk associated with the use of the on-x valve.Product met all specifications prior to release and no deviations are noted with the processing of this product.This event does not identify additional hazards or modify the probability and severity of existing hazards.

Event Description

According to an email forwarded on 01/03/2018: "dear [manufacturer representative] , we met [physician] some time back.He had 2 mitral valve patients who came back with a thrombosed and stuck valve.Both the patients were thrombolysed.One patient suffered stroke and could not survive.The second also suffered peripheral embolism and suffered organ faliure [failure] and could not survive.The first patient was admitted with an inr of 1.2 and the second patient with an inr of 1.9.This has led the doctor to percieve [perceive] that on-x is more thrombogenic in camparison [comparison] to other mechanical valves." this case is in reference to the second patient who passed due to organ failure.A separate report has been submitted for the first patient.

• Brand Name: ON-X PROSTHETIC MITRAL VALVE 25MM
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd. nw; kennesaw, GA 30144
• MDR Report Key: 7210542
• MDR Text Key: 97941240
• Report Number: 1649833-2018-00003
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXM-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/23/2017
• Date Manufacturer Received: 12/23/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other