MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COSGROVE-EDWARDS ANNULOPLASTY SYSTEM; RING, ANNULOPLASTY

Model Number 4600

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Mitral Regurgitation (1964)

Event Date 05/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned to edwards for evaluation.The device history record (dhr) was unable to be reviewed as the device serial number is unknown.Systolic anterior motion of the mitral valve may occur after mitral valve annuloplasty.It is typically due to redundant native leaflet tissue and may result in left ventricular outflow obstruction after mitral valve repair.This may require additional leaflet resection or a mitral valve replacement.A definitive root cause could not be determined.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

Edwards received information a 38mm mitral annuloplasty ring was explanted at implant due to systolic anterior motion (sam).Patient was reported to have a barlow valve with a very large anterior and posterior leaflet.It was reported the patient was first implanted with a non-edwards 34mm ring but when patient was taken off bypass, there was moderate to severe mitral regurgitation because of systolic anterior motion of the mitral valve leaflet.The 34mm ring was explanted and replaced with the 38mm ring.When came off bypass again, there was moderate to severe mitral regurgitation due to sam.The explanted ring was replaced with a 25/33 non-edwards mechanical valve.The patient also underwent maze during the procedure.Patient had evidence of heart block so epicardial right ventricular wires were placed.Patient was transferred to the intensive care unit in stable condition.

Manufacturer Narrative

The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.The device was not returned to edwards for evaluation as it was discarded.Based on the information received patient factors and surgical technique may have contributed to the event.

Manufacturer Narrative

H10.Additional manufacturer narrative: udi number: (b)(4).

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: COSGROVE-EDWARDS ANNULOPLASTY SYSTEM
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8921290
• MDR Text Key: 155227634
• Report Number: 2015691-2019-03114
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• PMA/PMN Number: K923367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2023
• Device Model Number: 4600
• 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): Required Intervention
• Patient Age: 63 YR