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

Model Number 4600

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hemolysis (1886)

Event Date 04/25/2005

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it was discarded.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.In this case, the patient underwent mitral valve repair and developed subsequent hemolysis in the early postoperative period and required valve replacement.A manufacturing related issue was not identified.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 that a 32mm ring implanted for 12 days was explanted due to hemolysis.A 29mm non-edwards valve was implanted in replacement.The patient was discharged on pod #4.

Manufacturer Narrative

H11.Corrected data: updated sections b2 and h6.

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: 10088658
• MDR Text Key: 192143847
• Report Number: 2015691-2020-11969
• 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,Followup
• Report Date: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2009
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 77 YR