MAUDE Adverse Event Report: EDWARDS LIFESCIENCES; REPLACEMENT HEART VALVE

Device Problems Degraded (1153); Torn Material (3024)

Patient Problem No Information (3190)

Event Date 03/20/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it was reported to have been discarded.The device history record (dhr) review could not be performed as the serial number is unknown.Attempts to retrieve additional information were unsuccessful.Bioprosthetic valves have been proven to have excellent long term durability.Replacement of a bioprosthetic valve over time is more likely due to structural valve deterioration (svd) which occurs as a result of stenosis (from calcification or host tissue overgrowth), dehiscence, fibrosis or non-calcific degeneration or endocarditis.These are typically due to patient factors such as age, gender, and prior medical history of hypertension, diabetes and renal disease.Based on the information received the cause of the event cannot be determined; however, patient factors may have contributed.If additional information is received a supplemental mdr will be submitted.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

Edwards received information a valve was explanted after an implant duration of approximately two to three years due to progressive valve deterioration.Through follow-up, it was learned that the valve had a leaflet tear with no calcification.No other information was provided.

• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: trushala nerurkar ; 1 edwards way; ms lfs 33; irvine, CA 92614 ; 9492501377
• MDR Report Key: 6540661
• MDR Text Key: 74299634
• Report Number: 2015691-2017-01194
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: DR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2017
• 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