MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PHYSIO FLEX ANNULOPLASTY RING

Model Number 5300

Device Problem Material Deformation (2976)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2021

Event Type  Injury  

Manufacturer Narrative

Surgeons often attempt to repair valves in lieu of replacing them due to improved long-term clinical outcomes.There are times when a valve repair is attempted using an annuloplasty ring and subsequent post-repair evaluation demonstrates an inadequate result.This is almost universally due to suboptimal anatomy, surgical technique, or inappropriate sizing, and not a malfunction of the annuloplasty ring.The device was returned and product evaluation is ongoing.Minimal information regarding this procedure was received and attempts to get additional information regarding the condition of the device, patient's medical history, or possible comorbidities have been unsuccessful.The root cause of the event remains indeterminable.If new information becomes available, a supplemental report will be submitted.

Event Description

It was reported that a 34mm mitral ring was explanted at implant due to nitinol wire punctured through the dacron fabric.A non-edwards valve was implanted.There were no patient complications.As reported, the surgeon did this procedure as a robotic minimally invasive mitral valve repair.The surgeon took the ring off the holder prior to implanting it and inserted it via a 12mm port.He had to explant it because once it was implanted and tied down with cor knots it was noted the nitinol wire had punctured through the dacron fabric on the ring.The surgeon is experienced with edwards ring devices.

Manufacturer Narrative

H10: additional narratives updated b5 per new information received.

Event Description

It was reported that a 34mm mitral ring was explanted at implant due to nitinol wire punctured through the dacron fabric.A non-edwards valve was implanted.There were no patient complications.As reported, the surgeon did this procedure as a robotic minimally invasive mitral valve repair.The surgeon took the ring off the holder prior to implanting it and inserted it via a 12mm port.He had to explant it because once it was implanted and tied down with cor knots it was noted the nitinol wire had punctured through the dacron fabric on the ring.The surgeon believed he was manipulating/pulling the dacron of the ring a bit too much and that is what caused the issue.The surgeon is experienced with ew ring devices.

Manufacturer Narrative

H3: product evaluation.Customer report of exposed nitinol wire was confirmed.As received, the core wire of the ring was found extending out from the sewing ring cloth of the ring at one end.X-ray demonstrated ring intact.The sewing ring cloth was cut at multiple locations around the ring.Straight and even cuts across the cloth bundles were observed on the cuts.Silicone cuts were observed underneath some of the cloth cuts.

Manufacturer Narrative

Based on the provided information and the evaluation, the cause of the event is use error of excessive manipulation of the ring for robotic implantation without the holder.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.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.

• Brand Name: CARPENTIER-EDWARDS PHYSIO FLEX ANNULOPLASTY RING
• Type of Device: ANNULOPLASTY RING
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: gail warner ; one edwards way; mailstop 6.1 anton; irvine, CA 92614 ; 9492504096
• MDR Report Key: 12321239
• MDR Text Key: 266502301
• Report Number: 2015691-2021-04684
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2021
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female