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

Model Number ONXM-27/29

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

Patient Problems Congestive Heart Failure (1783); Regurgitation, Valvular (2335)

Event Date 09/11/2018

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 the initial report , a (b)(6) male with history of mitral, aortic and tricuspid insufficiency, congestive heart failure (chf), hypertension, former smoker with family history of coronary artery disease (cad), presented with sob (shortness of breath) on (b)(6) 2017 (just 2 months after the first operation (implantation of onxm 27/29, serial number (sn) (b)(4) on (b)(6) 2017).On (b)(6) 2017 it was noted in the clinical chart that the patient would need a redo mvr (mitral valve replacement) due to echocardiography demonstrates severe mitral insufficiency.270 degree paravalvular leak(pvl).On (b)(6) 2018 transthoracic echocardiogram performed at pima heart non-invasive lab and resulted in mv c/w mechanical valve.Grossly nl (normal) function.Trace to mild mr.After this visit ((b)(6) 2017) the patient followed up with the surgeon once a month until the redo surgery on (b)(6) 2018.

Manufacturer Narrative

The manufacturing records for on-x mitral 27/29, serial number (b)(4) were reviewed and it was determined that the valve met specifications for release.Endocarditis is the primary contributor leading to the need for reoperation, explantation, and replacement of the previous mitral prosthetic heart valve.There is no indication the on-x valve had any relationship to the complications necessitating its removal and 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 initial report , a 55 year old male with history of mitral, aortic and tricuspid insufficiency, congestive heart failure (chf), hypertension, former smoker with family history of coronary artery disease (cad), presented with sob (shortness of breath) on (b)(6) 2017 (just 2 months after the first operation (implantation of onxm 27/29, serial number (b)(4) on (b)(6) 2017 on (b)(6) 2017 it was noted in the clinical chart that the patient would need a redo mvr (mitral valve replacement) due to echocardiography demonstrates severe mitral insufficiency.270 degree paravalvular leak(pvl).(b)(6) 2018 transthoracic echocardiogram performed at pima heart non-invasive lab and resulted in mv c/w mechanical valve.Grossly nl (normal) function.Trace to mild mr.After this visit (b)(6) 2017 the patient followed up with the surgeon once a month until the redo surgery on (b)(6) 2018.

• Brand Name: ON-X MITRAL 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: 7969025
• MDR Text Key: 123819720
• Report Number: 1649833-2018-00155
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXM-27/29
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/19/2018
• Date Manufacturer Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR