MAUDE Adverse Event Report: CRYOLIFE, INC. ONX MITRAL STANDARD 27/29; HEART-VALVE, MECHANICAL

Model Number ONXM-27/29

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

Patient Problems Regurgitation (2259); Valvular Stenosis (2697)

Event Date 03/31/2016

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 an email received on (b)(6) 2018: "identified disease on the patient is mitral regurgitation and stenosis.The contribution factor of replacement was pseudoaneurysm on lv (left ventricle) accompanied by lv rupture.No infection was confirmed.According to the surgeon conducting the revision surgery, the explanting valve looks no problem at sight, but not sure of hidden issue and therefore he would like [manufacturer] to examine it in detail and provide an investigational report.".

Manufacturer Narrative

A review of the manufacturing records revealed that the product met all specifications and passed all manufacturing test.Another review was held of the available information.The product was explanted on (b)(6) 2016.No date of implant is given hence duration of implant could not be calculated.Report from the field is that the patient experienced mitral regurgitation and stenosis as well as left ventricular (lv) pseudoaneurysm and lv rupture.No echocardiogram was given to verify these observations.There was no evidence of infection.Although the valve appeared normal on explant, the surgeon requested an analysis of the valve for any "hidden issue." the valve was returned and examined, minor non-obstructive tissue growth was noted on the perimeter of the inflow side.All manufacturing specifications were found to be within acceptable limits.Lv pseudoaneurysm is generally associated with myocardial infarction, but no other patient information is present to confirm or deny its contribution.Because the valve examination came back normal, no evidence was obtained to attribute the lv pseudoaneurysm and rupture to the valve performance.Consequently, no sufficient evidence to attribute what, if any, contribution the valve had to the development of stenosis, regurgitation, lv pseudoaneurysm, or lv rupture.In any case, heart failure, myocardial infarction, prosthesis nonstructural dysfunction, prosthesis regurgitation, and the possibility of reoperation and explantation are all acknowledged as potential adverse events in the products instructions for use.

Event Description

According to an email received on (b)(6) 2018: "identified disease on the patient is mitral regurgitation and stenosis.The contribution factor of replacement was pseudoaneurysm on lv (left ventricle) accompanied by lv rupture.No infection was confirmed.According to the surgeon conducting the revision surgery, the explanting valve looks no problem at sight, but not sure of hidden issue and therefore he would like [manufacturer] to examine it in detail and provide an investigational report.".

• Brand Name: ONX MITRAL STANDARD 27/29
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): CRYOLIFE, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): CRYOLIFE, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd. nw; kennesaw, GA 30144 ; 6782904624
• MDR Report Key: 7592031
• MDR Text Key: 110795882
• Report Number: 1649833-2018-00111
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ONXM-27/29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/15/2018
• Date Manufacturer Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other