MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS MC3 TRICUSPID ANNULOPLASTY RING

Model Number 4900

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

Patient Problems Tricuspid Regurgitation (2112); No Information (3190)

Event Date 11/17/2016

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: the device was not returned to edwards for evaluation as it remains implanted.The device history record (dhr) was not reviewed as the reported event does not allege a malfunction that could be related to a manufacturing deficiency and/or one was not confirmed through investigation.Attempts to retrieve additional information are in process.Without additional information the cause of the event remains indeterminable; however, patient factors may have contributed to the event.If additional information is received a supplemental mdr will be submitted.Trends will continue to be monitored through the use of edwards quality systems and if action is required, appropriate investigation will be performed.

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, edwards learned 19mm aortic valve was disabled after an implant duration of 11 years, three months, due to unknown reasons.A second device, a 29mm transcatheter valve, was implanted in the aortic position using a valve-in-valve procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The annuloplasty ring was not returned to edwards for evaluation as it remains implanted.The device history record (dhr) was not reviewed as the reported event does not allege a malfunction that could be related to a manufacturing deficiency and/or one was not confirmed through investigation.Based on the information received, patient factors likely contributed to the event.

Event Description

Through follow up with the healthcare provider edwards learned a patient with a 26mm tricuspid ring implanted for approximately 11 years, three months, required transcatheter valve-in-ring procedure due to severe tricuspid regurgitation.A second device, a 29mm transcatheter valve, was implanted inside the 26mm ring in the tricuspid position via valve-in-ring procedure.The patient was discharged on postoperative day 25 to an acute care facility.The patient also has edwards aortic and mitral valves that remain implanted.

• Brand Name: EDWARDS MC3 TRICUSPID ANNULOPLASTY RING
• Type of Device: ANNULOPLASTY RING
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: trushala nerurkar ; 1 edwards way; ms lfs 33; irvine, CA 92614 ; 9492501377
• MDR Report Key: 6177815
• MDR Text Key: 62461750
• Report Number: 2015691-2016-03724
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2016

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: 04/30/2010
• Device Model Number: 4900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR