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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES COSGROVE-EDWARDS® ANNULOPLASTY SYSTEM RING, ANNULOPLASTY Back to Search Results
Model Number 4600
Device Problems Heart Valve Leaflet (466); Incomplete Coaptation (2507)
Patient Problem 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".

 
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Brand NameCOSGROVE-EDWARDS® ANNULOPLASTY SYSTEM
Type of DeviceRING, ANNULOPLASTY
Manufacturer (Section D)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
1 edwards way
irvine CA 92614
Manufacturer Contact
amritha srinivasan
1 edwards way
mle2
irvine, CA 92614
9492502289
MDR Report Key8531276
MDR Text Key142480898
Report Number2015691-2019-01375
Device Sequence Number1
Product Code KRH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK923367
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial
Report Date 03/26/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/19/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/21/2019
Device MODEL Number4600
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/22/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/19/2019 Patient Sequence Number: 1
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