MAUDE Adverse Event Report: EDWARDS LIFESCIENCES STARR EDWARDS SILASTIC BALL VALVE; HEART-VALVE, MECHANICAL

Model Number 6120T

Device Problems Calcified (1077); Perivalvular Leak (1457); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 05/06/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation.The device history record (dhr) was unable to be reviewed as the device serial number was not provided.Valve dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate prosthetic valve implantation in combination with friable myocardial tissue.Late dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease or from endocarditis.A definitive root cause could not be determined; however, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

Edwards received notification that a valve implanted in the mitral position was explanted after an implant duration of 46 years due to valve detachment.A non-edwards device was implanted in replacement.No other information on valve and patient was able to be obtained.As reported, the patient was (b)(6) years old at the time of initial implant.

Manufacturer Narrative

Updated report of calcification and valve detachment could not be confirmed through image evaluation.One color photo of mechanical valve was provided.Mechanical valve appeared to have a metallic ball and four cloth covered struts with host tissue overgrowth.Cloth appeared cut at one of the cloth covered struts of the valve.Multiple sutures remained attached to its sewing ring.

Event Description

Edwards received notification that this edwards valve implanted in the mitral position was explanted after an implant duration of 46 years due to calcification leading to valve detachment.A non-edwards device was implanted in replacement.The patient was noted to be in good condition.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: STARR EDWARDS SILASTIC BALL VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8675810
• MDR Text Key: 147237823
• Report Number: 2015691-2019-02033
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P870038/S007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6120T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention