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 Corneal Pannus (1447); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965)

Event Date 07/27/2016

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: the device was not returned to edwards for evaluation as healthcare provider reported it was discarded.The device history record (dhr) was not reviewed as the reported event does not allege a malfunction that could be related to a manufacturing deficiency and/or one was not confirmed through investigation.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.Based on the information received the cause cannot be determined; however, patient factors may have contributed to the event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

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.In this case, edwards learned a 32mm mitral ring was explanted after an implant duration of two years, one month, due to severe mitral regurgitation, mitral valve prolapse, and moderate stenosis.At explant of the 32mm ring it was noted there was severe fibrosis thickening related to the annuloplasty ring."there was also very severe pericardial reaction suggesting probable rheumatic pericarditis." the explanted device was replaced with a 27mm mitral valve.The patient tolerated the procedure well.Patient is status seven on the heart transplant list.Patient was discharged on post operative day 14.

Manufacturer Narrative

(b)(4).

• Brand Name: COSGROVE-EDWARDS® ANNULOPLASTY SYSTEM
• Type of Device: ANNULOPLASTY RING
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; ms mle-2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 6095623
• MDR Text Key: 59719426
• Report Number: 2015691-2016-03348
• 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,use
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2016

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: 06/10/2017
• Device Model Number: 4600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2016
• Initial Date FDA Received: 11/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 15 YR
• Patient Weight: 51