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

Model Number 4600

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 04/02/2019

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 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 via the implant patient registry that a 38mm mitral ring, implanted approximately for nine (9) months, was explanted due to severe mitral regurgitation from hemolytic anemia.Tte demonstrated severe mitral regurgitation with a jet directed posteriorly against the annuloplasty band.The explanted device was replaced with a 29mm bioprosthetic valve.Patient was weaned from cpb without difficulty.Echocardiogram showed both valves appeared to function normally with good leaflet motion and no regurgitation.The patient was transferred to icu in stable condition and discharged on pod #4 in good condition.

Manufacturer Narrative

Device evaluation: customer report of regurgitation could not be confirmed though visual observations.X-ray demonstrated ring intact.Minimal host tissue growth was observed on ring.Multiple sutures remained on the ring.

Manufacturer Narrative

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

• Brand Name: COSGROVE-EDWARDS ANNULOPLASTY SYSTEM
• Type of Device: ANNULOPLASTY RING
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8575725
• MDR Text Key: 143934911
• Report Number: 2015691-2019-01574
• 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: 04/10/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2023
• Device Model Number: 4600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: 05/10/2019; 07/23/2020
• Supplement Dates FDA Received: 06/04/2019; 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 81