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

Model Number 5200

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 04/24/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation.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.Based on the information received the cause of the event cannot be determined.If additional information is received a supplemental mdr will be submitted.No further corrective or preventative actions are required at this time.Edwards lifesciences will continue to monitor all reported events.

Event Description

It was reported via the implant patient registry this ring implanted in the mitral position was explanted after an implant duration of 5 years and 3 months for unknown reason.An id card was received with question "was this due to a deficiency of the original device?" marked as "yes".A 32mm ring was implanted in replacement.No other information was provided.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8748228
• MDR Text Key: 149640663
• Report Number: 2015691-2019-02389
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/07/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2018
• Device Model Number: 5200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 07/01/2019
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR