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

Model Number	5200
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Dyspnea (1816); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	04/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to edwards for evaluation.Attempts to retrieve device and additional information is in process.If additional information is received a supplemental mdr will be submitted.The device history record was reviewed and shows that this device met all manufacturing specifications for product release prior distribution.No issues were identified that would have impacted this event.Ring dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate valve repair in combination with friable myocardial tissue.Late dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease.The cause of the event cannot be determined; however, patient factors and progression of underlying valvular disease may have impacted the 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.
Event or Problem Description
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.Edwards implant patient registry received information a 36mm mitral ring was explanted after two (2) years, due dehiscence of suture around 12 and 4 o'clock which led to severe mitral regurgitation and mitral valve prolapse.Patient presented with recurrent dyspnea on exertion and was found to have severe mitral regurgitation on echo.The explanted ring was replaced with a 36mm ring and placement of goretex neochords.The patient was transferred to the icu in stable but critical condition.
Additional Manufacturer Narrative
The cause of the event was due to patient factors and progression of patients underlying valvular disease.

• Brand Name: CARPENTIER-EDWARDS PHYSIO II RING
• Common Device Name: ANNULOPLASTY RING
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 12143829
• Report Number: 2015691-2021-03976
• Device Sequence Number: 4215113
• Product Code: KRH
• UDI-Device Identifier: 00690103180183
• UDI-Public: (01)00690103180183(17)240122
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K083470
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2024
• Device Model Number: 5200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 31 YR