MAUDE Adverse Event Report: EDWARDS LIFESCIENCES GEOFORM ANNULOPLASTY RING MITRAL

Model Number 4200

Device Problems Perivalvular Leak (1457); Appropriate Term/Code Not Available (3191)

Patient Problem Mitral Regurgitation (1964)

Event Date 01/03/2014

Event Type  Injury  

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, it was reported that a (b)(6) female underwent a ring explant after an implant duration of one (1) year, ten (10) months.Through follow up with the health care provider, it was learned that the reason for explant was not due to a malfunction of the device but due to dehiscence, regurgitation, and pv leak.No additional details provided.

Manufacturer Narrative

Dehiscence.Device not returned.Additional manufacturer narrative the explanted device was not returned to edwards for analysis.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections.Without return of the device, edwards is unable to conclusively determine the root cause for this event.Reoperations secondary to dehiscence are primarily the result of a progression of disease and not a malfunction of the device.No further actions are possible with the available information.

• Brand Name: GEOFORM ANNULOPLASTY RING MITRAL
• 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: lfs 33; irvine, CA 92614 ; 9492502289
• MDR Report Key: 3710962
• MDR Text Key: 4245246
• Report Number: 2015691-2014-00725
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/28/2014

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: 09/07/2016
• Device Model Number: 4200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2014
• Initial Date FDA Received: 03/31/2014
• Date Device Manufactured: 09/14/2011
• 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): Hospitalization; Required Intervention
• Patient Age: 68 YR