MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING; RING, ANNULOPLASTY

Model Number 5200

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Mitral Valve Stenosis (1965); Fibrosis (3167)

Event Date 03/21/2016

Event Type  Injury  

Manufacturer Narrative

Additional manufacturing narrative: 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.The explanted annuloplasty ring was not returned for evaluation; therefore, the reported event cannot be confirmed.The root cause of this event cannot be conclusively determined with the available information.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.No corrective action is applicable to this case; however, edwards will continue to review and monitor all reported 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, it was reported that an edwards mitral annuloplasty ring, implanted one (1) year, eight (8) months and twenty three (23) days, was explanted due to mitral stenosis.Per the medical records, there was severe fibrosis of the mitral apparatus covering the chords, leaflets and the previously placed annuloplasty ring.Intraoperatively, the previous repair was intact but covered in fibrotic scar tissue.The ring was removed and an edwards pericardial valve was seated and secured without difficulty.Testing showed competency.The patient was taken to the icu in guarded condition.

Event Description

The patient was later discharged.

• Brand Name: CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING
• Type of Device: RING, 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: neil landry ; 1 edwards way; t&d 2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5699415
• MDR Text Key: 46561809
• Report Number: 2015691-2016-01813
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083470
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2016

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: 03/18/2019
• Device Model Number: 5200
• Device Lot Number: U-14C1107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2016
• Initial Date FDA Received: 06/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2014
• 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: 61 YR