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

Model Number	4600M28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Mitral Valve Stenosis (1965); Thrombosis/Thrombus (4440)
Date of Event	01/05/2022
Type of Reportable Event	Serious Injury
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 28mm 4600 mitral ring was explanted after 10 months, due to mitral regurgitation, mitral stenosis, and thrombus.The explanted device was replaced with a 25mm 7300tfx mitral valve.Patient presented with dyspnea on exertion.Per implantation data card, the explant was due to deficiency of the device.Patient was discharged home on post-operative day eight (8).
Additional Manufacturer Narrative
The device was not returned to edwards for evaluation.Attempts to retrieve device and additional information is in process.The cause of the event cannot be determined.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.
Additional Manufacturer Narrative
H10.Additional manufacturer narrative: added information to d4, h4, h6.The device history record 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.As found in literature, annuloplasty rings are an adjunct to the valve repair and recurrent regurgitation and/or stenosis occurs primarily as a result of progression of disease and is not related to a device malfunction.The cause of the event was most likely due to patient factors and progression of underlying valvular disease.
Additional Manufacturer Narrative
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 or Problem Description
It was reported the ring did not malfunction (no structural deficiency).

• Brand Name: COSGROVE-EDWARDS ANNULOPLASTY SYSTEM
• Common Device Name: 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: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 13506778
• Report Number: 2015691-2022-03873
• Device Sequence Number: 17162012
• Product Code: KRH
• UDI-Device Identifier: 00690103020526
• UDI-Public: (01)00690103020526(17)240225
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K923367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2022

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: 02/25/2024
• Device Model Number: 4600M28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 02/18/2022; 03/23/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 03/15/2022; 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 86 KG