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

Model Number 5200

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Mitral Insufficiency (1963); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965); Prolapse (2475)

Event Date 08/30/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation.The causes of re-operation for a failed annuloplasty repairs are well documented in the literature.Re-operations are primarily the result of a progression of disease or technical failures and are not related to product malfunctions.In this case, there is evidence that the mis-sizing of the ring led to stenosis, which led to explant of the ring.A definitive root cause cannot be determined.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

It was reported via the implant patient registry that a 26mm mitral ring was explanted after one (1) year and four (4) months due to severe mitral insufficiency, leaflet prolapse, and mitral stenosis secondary to an undersized ring.The patient received a non-edwards mitral valve in replacement.The patient was transferred to the icu in critical condition.Per medical records, the patient presented with severe mitral valve insufficiency and was referred for re-operative mitral valve replacement.Intraoperatively, operative findings were consistent with severe mitral insufficiency due to anterior leaflet prolapse and mitral stenosis secondary to an undersized ring.The mitral valve was excised and a 29mm non-edwards valve was implanted.The patient was transferred to the icu in critical condition.

Manufacturer Narrative

The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9172415
• MDR Text Key: 163923758
• Report Number: 2015691-2019-03722
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• PMA/PMN Number: K083470
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,stu
• Type of Report: Initial,Followup,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2022
• Device Model Number: 5200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR