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

Model Number 6120T

Device Problems Migration or Expulsion of Device (1395); Perivalvular Leak (1457)

Patient Problems Cardiac Arrest (1762); Death (1802); Mitral Regurgitation (1964); Myocardial Infarction (1969); Stenosis (2263)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

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.In rare occasions, during the initial implant procedure, a suture or sutures may tear through the annulus requiring valve exchange or repair with standard surgical techniques and does not lead to serious injury or death.In this case, there was intervention to treat the dehiscence that was performed after the initial implant surgery.The device was not returned for evaluation and follow up is in progress.Based on the available information, the root cause of the event was likely due to patient related factors and the progression of the patient's underlying valvular disease pathology.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

Through review of medical article "suture embolus to the left anterior descending: a rare cause of myocardial infarction in a redo valve patient" authors jay jefferies et al, the following events were identified as pertaining to a starr-edwards mechanical valve: as reported, this valve model 6120t(unknown size) implanted in the mitral position was explanted after an implant duration of approx.33 years due to dehiscence leading to moderate pvl.Per the article: a (b)(6) male had a previous history of an aortic valve repair and coarctation of aorta repair at 2 years of age, as well as a mechanical mitral valve replacement (mvr) at 15 years with a star edwards valve following endocarditis.He came forward for redo cardiac surgery due to severe aortic regurgitation, which was due to a bicuspid valve and a dilated ascending aorta, as well as a moderate paravalvular leak around his mechanical mvr.His other history was significant for permanent atrial fibrillation, and an echocardiogram showed mildly impaired left ventricular systolic function with an ejection fraction of 45%.Preoperative computed tomography coronary angiogram demonstrated a known 40-50% lad stenosis.The patient underwent a redo mechanical mvr and mechanical bentall procedure.On removal of the previous valve it was noted that the valve had dehisced from the annulus with deterioration of the annular silk sutures.A transthoracic echocardiogram was performed in the intensive care unit, due to haemodynamic instability, and this demonstrated marked ventricular desynchrony with mid-to-apical septal and anterolateral hypokinesis.The patient was planned for angiography, given the bentall procedure, but unfortunately had a cardiac arrest and was unable to be resuscitated.A post-mortem found an acute myocardial infarction as the cause of death and a 0.6-mm embolic fragment of silk suture in the lad that was at the site of the known previous lad stenosis.

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; 1 edwards way; irvine CA 92614
• MDR Report Key: 9318519
• MDR Text Key: 166596289
• Report Number: 2015691-2019-04211
• 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,health professional,l
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 48 YR