MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COSGROVE-EDWARDS® ANNULOPLASTY SYSTEM; HEART-VALVE, REPLACEMENT

Model Number 4600

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Mitral Valve Stenosis (1965)

Event Date 05/13/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Post-operatively, the body undergoes various phases of the tissue response continuum resulting in the fibrous encapsulation of the ring.Local and systemic factors of the patient may play a role in the wound healing and inflammatory responses to biomaterials and implants.A manufacturing related issue was not identified.A definitive root cause could not be determined.No further corrective or preventative actions are required at this time.Edwards will continue to review and monitor all events through the use of edwards quality systems.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received information that a 28 mm mitral ring, implanted three years, seven months was explanted due to stenosis secondary to severe scarring/host tissue.The explanted device was replaced with a 27 mm valve.It was also noted that patient had 4900 28 mm tricuspid ring implanted on the same day.The patient was discharged to home with home health in stable condition on pod #13.The patient developed post-op junctional rhythm and paf/flutter due to volume overload.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.

• Brand Name: COSGROVE-EDWARDS® ANNULOPLASTY SYSTEM
• Type of Device: HEART-VALVE, REPLACEMENT
• 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: neil landry ; 1 edwards way; lfs-33; irvine, CA 92614 ; 9492502289
• MDR Report Key: 6792906
• MDR Text Key: 82635875
• Report Number: 2015691-2017-02447
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2017

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: 08/21/2016
• Device Model Number: 4600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2017
• Initial Date FDA Received: 08/14/2017
• Date Device Manufactured: 09/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR