MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING

Model Number 6200T

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

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/13/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it remains implanted.Echo imaging was received and reviewed by third party echo imaging expert.Echo imaging impression: the submitted images are of poor quality and, without associated times of acquisition, are difficult to associate with specific surgical intervals.The images document ar after the first pump run, although the mechanism is not defined.The presence or absence of ar was not defined on the submitted pre-pump images, and an interval change cannot be confirmed.With very limited interrogation of the valve, it is unclear whether the appearance of aortic valve leaflet thickening and decreased leaflet motion during the post-pump #1 interval is real (albeit transient) or a function of imaging artifact.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.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

It was reported that a patient developed aortic regurgitation grade 3 during the surgery that was performed for mitral valvuloplasty with a mitral ring and tricuspid annuloplasty with a 28mm 6200t tricuspid ring.The surgery was performed in the order of mitral valvuloplasty (p3 triangular resection), pulmonary vein isolation, left atrial appendage closure, and tricuspid annuloplasty.After completing all procedures and releasing the aortic clamp, echo showed the aortic regurgitation.Because both ventricles had become swollen due to increased blood volume secondary to the regurgitation, the surgeon decided to perform an additional aortic valve replacement, so the aorta was re-clamped and a 19mm 11500aj aortic valve was implanted.The patient status was reported as recovered.Per the reported information, no sutures used to implant both rings were placed on the aortic side.According to the surgeon, mild ar was observed prior to the surgery, but no issues were confirmed in the aortic valve, such as leaflets thickening or immobility.The surgeon commented it was unknown regarding the causal relationship between this 6200t ring and the event.

• Brand Name: CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING
• 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 ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18297099
• MDR Text Key: 330113739
• Report Number: 2015691-2023-18251
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2023

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
• Device Model Number: 6200T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2023
• 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): Other; Hospitalization; Life Threatening