MAUDE Adverse Event Report: EDWARDS LIFESCIENCES; ANNULOPLASTY RING

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2014

Event Type  Injury  

Manufacturer Narrative

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.The device was not returned for evaluation, as there were no allegations of device malfunctions.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Event Description

It was learned from the received operative report that a 34mm physio ring in the mitral position was explanted at implant post decannulation due to systolic anterior motion (sam).Per medical records: the pre op tee showed severe mr with posterior directed jet.The patient underwent a myomectomy followed by a mitral repair with anterior leaflet chordae release and a 34mm physio ring.The ring seated well.The patient was weaned from cpb and decannulated.Post decannulation there appeared to be sam , and trace mr.The patient was re-cannulated and placed back on bypass.A further septal myomectomy was performed.The patient decannulated.A tee indicated increased sam with 2 to 3+mr.The patient was re-cannulated and placed back on cpb and underwent explant of the 34mm physio annuloplasty ring and mvr with a 29mm 7300tfx mitral valve.The valve was seated well without perivalvular leak.Mitral valve peak gradient was 4mmhg and outflow gradient after mvr and extended septal myomectomy was 7.8mmhg.The patient was transferred to cvicu.Concomitantly the patient underwent cabg x2.

Manufacturer Narrative

H10: additional narratives updated h6 per new information received the most likely cause is procedural factors.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.

• Brand Name: NI
• Type of Device: ANNULOPLASTY RING
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16095961
• MDR Text Key: 306633981
• Report Number: 2015691-2023-09954
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2022
• Initial Date FDA Received: 01/04/2023
• Supplement Dates Manufacturer Received: 02/17/2023
• Supplement Dates FDA Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Life Threatening; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male