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

Model Number 4600

Device Problem Incomplete Coaptation (2507)

Patient Problems Mitral Regurgitation (1964); Hemolytic Anemia (2279)

Event Date 01/18/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation.The device history record (dhr) 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.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.A definitive root cause could not be determined.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

It was reported via the implant patient registry that a 4600 38mm mitral ring, implanted for three (3) years and nine (9) months, was explanted due to hemolytic anemia and regurgitation.The explanted device was replaced with a 7300tfx 33mm bioprosthetic valve.Patient was discharged home on pod #6.Per medical records, this case involved a (b)(6) male with a history of mvr.He presented with hemolytic anemia and mitral regurgitation.A 4600 38mm mitral ring along with the anterior leaflet were excised.A 7300tfx 33mm bioprosthetic mitral valve was implanted using cor-knots.The patient was weaned from cpb without difficulty.Echocardiogram revealed well-seated valve with no perivalvular leak and mean gradient of 2.Patient tolerated the procedure and transferred to icu in stable condition.It was noted he was discharged home on pod #6.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".

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: COSGROVE-EDWARDS ANNULOPLASTY SYSTEM
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8531276
• MDR Text Key: 142480898
• Report Number: 2015691-2019-01375
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• PMA/PMN Number: K923367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2019
• Device Model Number: 4600
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR