MAUDE Adverse Event Report: EDWARDS LIFESCIENCES REPLACEMENT HEART VALVE; REPLACEMENT HEART-VALVE

Device Problems Therapeutic or Diagnostic Output Failure (3023); Appropriate Term/Code Not Available (3191)

Patient Problems Calcium Deposits/Calcification (1758); Stenosis of the esophagus (4487)

Event Type  Injury  

Event Description

Medtronic received information that a transcatheter valve was implanted in a failed edwards surgical aortic valve due to calcification and stenosis.No further adverse patient effects were reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: REPLACEMENT HEART VALVE
• Type of Device: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES
• MDR Report Key: 17535274
• MDR Text Key: 321045184
• Report Number: MW5142173
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2017

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1