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

Model Number 5300

Device Problems Inadequacy of Device Shape and/or Size (1583); Material Deformation (2976); Appropriate Term/Code Not Available (3191)

Patient Problem Mitral Regurgitation (1964)

Event Date 07/03/2020

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.In this case the possibility of device malfunction cannot be excluded; the risk of serious injury or death is not remote.The device was not returned for evaluation, as it was discarded.The root cause of this event cannot be conclusively determined.However, it is likely that patient related and/or procedural factors contributed to the event.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.

Event Description

Edwards learned that a 36 mm annuloplasty ring was explanted at implant due to mitral regurgitation.As reported, at implant, when knotting the sutures at posterior cusp area, the ring was deformed and it looked like pushing the posterior cusp.The nitinol core in the sewing cloth moved and pushed the posterior cusp, and the cloth of the sewing area was extended.This deformation affects the mobility of the posterior cusp, and mitral regurgitation got worse than before the surgery.The device was explanted and replaced with a 34 mm annuloplasty ring while the patient was on bypass.The surgeon commented that it was unknown whether this explant was device related.

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.

Event Description

Edwards learned that a 36mm mitral annuloplasty ring was explanted at implant due to mitral regurgitation.At implant, when knotting the sutures at posterior cusp area, the ring was deformed and it looked like pushing the posterior cusp.The nitinol core in the sewing cloth moved and pushed the posterior cusp, and the cloth of the sewing area was extended.This deformation affects the mobility of the posterior cusp, and mitral regurgitation got worse than before the surgery.The deice was explanted and replaced with a 34mm annuloplasty ring while the patient was on bypass.Surgery video was provided for image evaluation.Per image evaluation, sizing issue was the primary coding for the event.The surgeon commented that it was unknown whether this explant was device related.There was no patient adverse event associated with the ring replacement.

Manufacturer Narrative

H10: additional manufacturer narrative.Updated b5 per new information received.

Event Description

Edwards learned that a 36mm mitral annuloplasty ring was explanted at implant due to mitral regurgitation.At implant, when knotting the sutures at posterior cusp area, the ring was deformed and it looked like pushing the posterior cusp.The nitinol core in the sewing cloth moved and pushed the posterior cusp, and the cloth of the sewing area was extended.This deformation affects the mobility of the posterior cusp, and mitral regurgitation got worse than before the surgery.The deice was explanted and replaced with a 34mm annuloplasty ring while the patient was on bypass.Surgery video was provided for image evaluation.Per image evaluation, sizing issue was the primary coding for the event.The surgeon commented that it was unknown whether this explant was device related.There was no patient adverse event associated with the ring replacement.The patient status was reported as "recovered".

Manufacturer Narrative

Reference capa-20-00141.

Manufacturer Narrative

H11: corrected data: additional information obtained confirmed that there was no patient adverse event associated with the ring replacement for the previously reported event.The event was not related to the edwards valve.As such, this event is no longer considered reportable and this correction is being submitted.

• Brand Name: CARPENTIER-EDWARDS PHYSIO FLEX ANNULOPLASTY RING
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10334177
• MDR Text Key: 200770953
• Report Number: 2015691-2020-12745
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• PMA/PMN Number: K192762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• 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?: No
• Date Manufacturer Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 87