MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PHYSIO FLEX ANNULOPLASTY RING

Model Number 5300

Device Problems Fluid/Blood Leak (1250); Inadequacy of Device Shape and/or Size (1583); Detachment of Device or Device Component (2907)

Patient Problem Mitral Regurgitation (1964)

Event Date 09/18/2020

Event Type  Injury  

Manufacturer Narrative

The device has not yet been received.Attempts to retrieve the device and additional information is in process.If additional information is received a supplemental mdr will be submitted.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.The cause of the event cannot be determined.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 received notification a 32mm mitral ring implanted in the mitral position is was explanted after an implant duration of one (1) month, 28 days due to sizing issues leading to dehiscence, however no mitral regurgitation was observed.As reported, only 3 sutures on the posterior commissure remained intact.Indication for initial implantation was mitral regurgitation.Surgeon reported that he undersized the annulus as he had reduced visibility minimally invasively.A 36mm mitral ring was implanted successfully as replacement.No mitral regurgitation observed on echo.

Manufacturer Narrative

H3.Device evaluation: customer reports of "sizing issues leading to dehiscence" could not be confirmed through visual observations.X-ray demonstrated the ring to be intact.The ring had multiple cuts on the cloth; straight and even cuts were observed across the cloth bundles.Silicone was observed to be cut underneath some of the sewing cloth cuts.Multiple cor-knots remained attached around the ring.H10.Additional manufacturer narrative: the complaint could not be confirmed through visual observations.The cause of the event cannot be determined.Added information to d10, h3, h6.

• Brand Name: PHYSIO FLEX ANNULOPLASTY RING
• Type of Device: ANNULOPLASTY RING
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10692045
• MDR Text Key: 211860407
• Report Number: 2015691-2020-14001
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• PMA/PMN Number: K192762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 41 YR