MAUDE Adverse Event Report: EDWARDS LIFESCIENCES

Device Problems Mechanical Jam (2983); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Left Ventricular Dysfunction (1947); Right Ventricular Dysfunction (2054)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

The root cause of this event cannot be conclusively determined with the available information.However, the restricted ball motion exhibited by the mechanical valve in this case was most likely impacted by the progression of the patient¿s underlying valvular disease pathology.The subject device is not available for evaluation, as it remains implanted in the patient.The device history record (dhr) could not be reviewed, as the device serial number was not provided.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Upon review of a written article it was learned that a starr-edwards mechanical valve was explanted from a (b)(6) year old patient after an implant duration of five (5) years due to ball-variance.Despite treatment for fixed aortic valve obstruction, the patient continued to have disabling symptoms from septal hypertrophy and severe dynamic lvot obstructions with a gradient of 97mmhg at rest.The patient underwent high-risk surgical myectomy, with post-operative course complicated by severe right ventricular dysfunction.Despite aggressive resuscitation the patient progressed to profound cardiogenic shock and did not survive.

Manufacturer Narrative

Reference capa-20-00141.

• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9265928
• MDR Text Key: 167133893
• Report Number: 2015691-2019-04060
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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