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

Model Number 5200M

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Coagulation Disorder (1779); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965); Regurgitation, Valvular (2335)

Event Date 06/21/2019

Event Type  malfunction  

Manufacturer Narrative

Udi number: (b)(4).The device was not returned for the evaluation; therefore, no conclusion can be made as the cause of the reported 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 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, edwards implant patient registry received information a 32mm annuloplasty ring was explanted after an implant duration of 15 days due to mitral stenosis and regurgitation.The explanted device was replaced with a 29mm mitral valve.There was no evidence of any perivalvular leak.The patient also underwent tricuspid valve replacement with a 31mm edwards mitral tissue valve during the procedure.Once the patient was off bypass there was significant coagulopathy and two blood products were used.

Manufacturer Narrative

The device was not returned to edwards for evaluation as it was reported to have not been received by hospital pathology.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.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.Unlike prosthetic heart valves, annuloplasty rings are an adjunct to the valve repair.Based on the information received the cause cannot be conclusively determined; however, patient factors likely contributed to the event.

Manufacturer Narrative

Corrected data: f10, h6.Reference (b)(4).

• Brand Name: CARPENTIER-EDWARDS PHYSIO II RING
• Type of Device: ANNULOPLASTY RING
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8819480
• MDR Text Key: 154111651
• Report Number: 2015691-2019-02738
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2023
• Device Model Number: 5200M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 07/23/2019
• Supplement Dates Manufacturer Received: 07/29/2019; 07/23/2020
• Supplement Dates FDA Received: 08/11/2019; 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR