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

Model Number 6120

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 10/08/2017

Event Type  Injury  

Manufacturer Narrative

Minimal information regarding the explant procedure was received no additional information regarding the condition of the device, patient's medical history, or possible comorbidities were provided.The root cause of the event remains indeterminable.However, there has been no allegation of a product malfunction.If new information becomes available, a supplemental report will be submitted.The device history record (dhr) could not be reviewed, as the device serial number was not provided.However, the reported event does not allege a malfunction that could be related to a manufacturing deficiency and/or one was not confirmed through investigation.Edwards will continue to review of all reported events and perform trend analysis on a monthly basis.If action is required, appropriate investigation will be performed.

Event Description

It was learned that a starr-edwards silastic ball heart valve prosthesis implanted in the mitral position was explanted after an implant duration of 23 years for unknown reasons.No other information was provided.

Manufacturer Narrative

Through further investigation, it was learned that the subject device was explanted due to pannus formation, and replaced with a non-edwards device.Host fibrous (pannus) tissue growth is expected in all prosthetic/bioprosthetic heart valves and largely attributable to the host response (such as the foreign body reaction) to the implants.In vast majority cases, the pannus tissue is from surrounding native anatomy such as annulus.The time course and severity of pannus growth is largely variable among the patients.The underlying mechanism is still not fully understood, but it is generally believed that the patient factors (such as patient immune system, age, other comorbidities, local anatomy et.Al.) may play important roles in pannus growth in bioprosthetic heart valves.In vast majority cases, the pannus tissue is from surrounding native anatomy such as annulus.The time course and severity of pannus growth is largely variable among the patients.The underlying mechanism is still not fully understood, but it is generally believed that the patient factors (such as patient immune system, age, other comorbidities, local anatomy et.Al.) may play important roles in pannus growth in bioprosthetic heart valves.A manufacturing related issue was not identified.A definitive root cause cannot be determined; however, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event.No further corrective or preventative actions are required at this time.Edwards will continue to review and monitor all events through the use of edwards quality systems.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

• Brand Name: STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESIS
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; mle-2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 7085103
• MDR Text Key: 93804956
• Report Number: 2015691-2017-04132
• 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: foreign,other
• Type of Report: Initial,Followup
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6120
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention