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

Model Number 6120

Device Problems Perivalvular Leak (1457); Insufficient Information (3190)

Patient Problems Mitral Regurgitation (1964); No Known Impact Or Consequence To Patient (2692)

Event Date 09/02/2019

Event Type  malfunction  

Manufacturer Narrative

Although there are multiple root causes, valves are typically explanted because they are not functioning optimally.In this case, the valve was not explanted but requires an explant procedure.Reoperative valve surgery carries significant risk.Minimal information regarding this event was received and attempts to get additional information regarding the condition of the device, patient's medical history, or possible comorbidities have been unsuccessful.If new information becomes available, a supplemental report will be submitted.The device history record (dhr) was not able to be reviewed as the device serial number was not provided.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

As reported by the patient's husband, a starr-edwards mechanical valve implanted in the mitral position needs to be replaced after an implant duration of 48 years for unknown reason.The patient's husband would like to know how much it costs.No additional details were provided.

Event Description

As reported by the patient's husband, a starr-edwards mechanical valve model 6120 implanted in the mitral position needs to be replaced after an implant duration of 48 years due to pvl.As reported the issue was notice on a follow up echo.Patient was symptomatic with fatigue, chronic tiredness, tachycardia and hypertension.

Manufacturer Narrative

Additional manufacturer narrative: paravalvular leak (pvl) refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue.It may occur as a result of a lack of appropriate sealing of the valve at the annulus.In this case, the patient is symptomatic and intervention is required to treat the pvl.Based on the available information, the root cause of the event remains indeterminable.However, it is likely that patient related factors and the progression of the patient's underlying valvular disease pathology contributed to the event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESIS
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9129718
• MDR Text Key: 196556916
• Report Number: 2015691-2019-03605
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P870038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6120
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/02/2019
• Initial Date FDA Received: 09/27/2019
• Supplement Dates Manufacturer Received: 10/10/2019; 07/23/2020
• Supplement Dates FDA Received: 10/17/2019; 01/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1