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

Model Number ONXM UNK

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

Patient Problems Corneal Pannus (1447); Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

Multiple attempts were made to obtain the following clarifying information without success: serial number, the patient¿s current status, date of implant and date of event, pertinent patient co-morbidities, patient¿s historic inr levels up to the event, proposed etiology, and planned interventions.The product code, serial number, and definitive date of implant were unavailable.As such, the system could not be queried for potential serial numbers shipped to the hospital.This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the report "during a field visit with this surgeon he reported the following verbally.Aprox 3 weeks ago a patient was observed to have one stuck leaflet in his onx mitral valve during a 6 months follow up.The valve had stuck previously, however, had then, independently, started to work correctly.The surgeon reports they suspect thrombosis and possible pannus.The valve will be replaced during a planned procedure within two weeks.

Manufacturer Narrative

Multiple requests for additional clarifying information were made without success to acquire the following information: the patient¿s current status, date of implant, date of previous event in which valve ¿stuck¿, date of explant, indication for procedure, procedure performed, pertinent patient comorbidities, patient¿s historic inr [international normalized ratio] levels preceding and during event, product code, serial number, operative notes, and if the explanted valve would be returned to cryolife for evaluation.No response was received.The manufacturing record for the on-x mitral valve was not reviewed as the serial number was not provided.The system could not be queried for potential valves sent to the hospital as the definite date of implant was not provided.A review of the available information was performed.It was reported that an unidentified and unconfirmed on-x mitral valve at a 6-month follow-up visit demonstrated impaired leaflet motion consistent with either thrombus or pannus or both.Plan was to explant the valve in approximately 3 weeks, but no further information became available.The valve was not returned to the manufacturer for analysis.No record of anticoagulation therapy was presented.With the very limited information we have, we cannot confirm this experience is that involving an on-x valve.However, the complications of thrombus and pannus are both listed as risks for prosthetic mitral valve replacement in the instructions for use [ifu] and explantation is a potential outcome.We have no objective medical evidence or records to confirm the stated observations.This is a potential mitral valve thrombosis and/or pannus of unknown origin and unknown outcome.The genesis of neither is known.The age would be about 6 months.While thrombosis and pannus are recognized potential complications associated with prosthetic mitral valve replacement [instructions for use], their occurrence is relatively rare.Objective performance criteria report an historical thrombosis incidence of 0.8% per valve-year for all rigid prosthetic valves [iso 5840:2005].The ifu lists the complications of thrombus and pannus as risks for prosthetic mitral valve replacement.This event does not identify additional hazards or modify the probability and severity of existing hazards.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.

Event Description

According to the report "during a field visit with this surgeon he reported the following verbally.Aprox 3 weeks ago a patient was observed to have one stuck leaflet in his onx mitral valve during a 6 months follow up.The valve had stuck previously, however, had then, independently, started to work correctly.The surgeon reports they suspect thrombosis and possible pannus.The valve will be replaced during a planned procedure within two weeks.".

• Brand Name: ON-X MITRAL VALVE UNKNOWN
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ONX LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ONX 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: 6889833
• MDR Text Key: 87204840
• Report Number: 1649833-2017-00070
• 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: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXM UNK
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/28/2017
• Date Manufacturer Received: 08/28/2017
• 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): Hospitalization; Life Threatening; Other