MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PHYSIO II RING; RING, ANNULOPLASTY

Model Number 5200M

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

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 09/12/2023

Event Type  Injury  

Event Description

It was learned from the implant patient registry that a 34mm mitral ring was explanted and replaced with a 30mm mitral ring after an implant duration of 1 year, 9 months due to regurgitation.The perceived root cause of the event is due to structural deficiency/damage of the annuloplasty ring.The patient was stable in the icu post procedure.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital and patient family members) and is not received in the form of a conventional "customer complaint." the information reported may or may not be related to the edwards device.

Manufacturer Narrative

There is evidence of device-related harm or structural deficiency of the ring that could cause or contribute to a serious injury.The device was not returned for evaluation, as device request is still ongoing.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Manufacturer Narrative

The most likely cause is patient factors, including progression of the patients valvular disease.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.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: CARPENTIER-EDWARDS PHYSIO II RING
• Type of Device: RING, ANNULOPLASTY
• 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; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18088082
• MDR Text Key: 327566466
• Report Number: 2015691-2023-17309
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00690103180220
• UDI-Public: (01)00690103180220(17)261012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083470
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2023

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: 5200M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 12/04/2023
• Supplement Dates FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• 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): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Male