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

Model Number	4600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemolytic Anemia (2279)
Date of Event	10/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional manufacturer narrative: the device was not returned to edwards for evaluation.Attempts to retrieve device is in process.A supplemental mdr will be submitted once new information is received or upon completion of the investigation.Hemolytic anemia results from the premature destruction of red blood cells.It has multiple etiologies including autoimmune diseases, genetic disorders, infection, and drug reactions.There are several mechanisms for hemolytic anemia after mitral valve repair.It may be related to the mitral valve repair prosthesis and/or the annuloplasty ring when there is a jet of blood flow created from a para-ring leak, if there is a regurgitant jet directly pointed at the annuloplasty ring or if there is rapid acceleration of the jet within a narrow zone of para-ring dehiscence.The cause of the event cannot be determined at this time; however, patient factors may have contributed to 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.Through the implant patient registry, it was learned that a patient with a 32mm 4600 mitral ring, was explanted after three months, 4 days due to a suture tear in the posterior leaflet of the mitral valve resulting in hemolytic anemia.The explanted ring was replaced with a 27mm 7300tfx mitral valve.The ring was removed and replaced with a with 27mm 7300tfx.The valve seated nicely without any leak.
Additional Manufacturer Narrative
H11: corrective data: based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

• 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: 13003769
• Report Number: 2015691-2021-06827
• Device Sequence Number: 4316781
• Product Code: KRH
• UDI-Device Identifier: 00690103020540
• UDI-Public: (01)00690103020540(17)250217
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2022

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 Model Number: 4600
• 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: 11/19/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male