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

Model Number 5200

Device Problems Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

Patient Problems Mitral Regurgitation (1964); Organ Dehiscence (2502)

Event Date 04/27/2020

Event Type  Injury  

Manufacturer Narrative

Udi (b)(4).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.Ring dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate valve repair in combination with friable myocardial tissue.Late dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease or from endocarditis.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

It was reported that a 28mm ring was explanted after six months due to dehiscence and severe eccentric mitral regurgitation.A 30mm ring was implanted in replacement.The mitral valve was interrogated showing no residual mitral regurgitation.The patient also received a 32mm 5200 ring in tricuspid position.The tricuspid valve was interrogated showing no residual tricuspid regurgitation.The patient tolerated the procedure well and was transferred to the icu in stable condition.The patient was discharged on pod #7 in good condition.There is no allegation of ring malfunction.

Manufacturer Narrative

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

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-0014.

• 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: 10121367
• MDR Text Key: 194108594
• Report Number: 2015691-2020-12067
• 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: 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