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

Model Number 5200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770)

Event Date 10/18/2019

Event Type  Injury  

Manufacturer Narrative

Udi (b)(4).The device was not returned to edwards for evaluation as it remains implanted.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.Atrial fibrillation (af) is a common arrhythmia in patients undergoing cardiac surgery, including valve replacement.It is a common pre-existing condition, can be associated with the procedure, or can be a progression of the patient¿s disease at some point in the post-operative period.Although a well-recognized complication of heart surgery, it is typically not related to the device, but the procedure or underlying cardiac disease.It has been demonstrated that post-operative af tends to occur within 2 to 4 days after the procedure, with a peak incidence on postoperative day 2.70% of patients develop this arrhythmia before the end of post-operative day 4 and 94% before the end of post-operative day 6.Thus, events of atrial fibrillation occurring beyond the first postoperative week are much more likely to be due to the patient's underlying pathophysiology, rather than the implantation procedure.A manufacturing related issue was not identified.A definitive root cause could not be determined.If additional information is received a supplemental mdr will be submitted.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

Edwards learned that a patient with a 28mm 5200 ring implanted for four days had a post operative course complicated by atrial fibrillation with slow ventricular response.The patient received a dual chamber pacemaker.After discharge, the patient suffered a stroke with resulting mild dysarthria.

Manufacturer Narrative

H11.Corrected data- updated section h6 (result and conclusion).

Manufacturer Narrative

Corrected data: f10, h6.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: 10121334
• MDR Text Key: 194133683
• Report Number: 2015691-2020-12066
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2024
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR