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

Model Number 5200

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Mitral Regurgitation (1964); Fibrosis (3167)

Event Date 10/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Host fibrous (pannus) tissue growth is expected in all prosthetic/bioprosthetic heart valves and annuloplasty rings, and is largely attributable to the host response (such as the foreign body reaction) to the implants.In vast majority cases, the pannus tissue is from surrounding native anatomy such as annulus.The time course and severity of pannus growth is largely variable among the patients.The underlying mechanism is still not fully understood, but it is generally believed that the patient factors (such as patient immune system, age, other comorbidities, local anatomy et.Al.) may play important roles in pannus growth.The reported event cannot be confirmed since the device was not returned for evaluation.However, it has been determined that patient related factors likely contributed to this event.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

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, it was learned that a mitral annuloplasty ring, implanted for two (2) years and four (4) months, was explanted due to severe mitral regurgitation.It was reported the patient presented with recurrent symptomatic mitral valve regurgitation on the basis of posterior leaflet prolapse.The ring appeared to be in the hinge point and there was some fibrosis from the ring and the leaflet.The ring was explanted and replaced with another edwards annuloplasty ring.The patient also underwent tricuspid valve repair during the procedure.Post-bypass transesophageal echocardiogram showed an excellent valve re-repair with no residual regurgitation.The patient was taken to the icu in stable condition.The patient was discharged home in stable condition on pod #5.

Manufacturer Narrative

The report of regurgitation could not be confirmed through visual observations.Returned was the ring which had been dismantled.Fragments of ring the sewing cloth and silicone were returned.Host tissue was observed on some of the cloth fragments.The x-ray demonstrated the ring to be intact.Due to the condition of the returned device, the reported event could not be confirmed.

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: 8061947
• MDR Text Key: 126950202
• Report Number: 2015691-2018-04654
• 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: 10/18/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2020
• Device Model Number: 5200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Initial Date Manufacturer Received: 10/18/2018
• Initial Date FDA Received: 11/12/2018
• Supplement Dates Manufacturer Received: 11/20/2018; 07/23/2020
• Supplement Dates FDA Received: 12/06/2018; 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 73