MAUDE Adverse Event Report: EDWARDS LIFESCIENCES STARR-EDWARDS¿ SILASTIC BALL HEART VALVE PROSTHESIS; HEART-VALVE, MECHANICAL

Model Number 1260

Device Problem Material Integrity Problem (2978)

Patient Problems Corneal Pannus (1447); Aortic Regurgitation (1716)

Event Date 04/24/2013

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards as the hospital was not able to release the device.Through follow up, the hospital confirmed that further information cannot be released and provided to edwards.There are many factors that could result in the need to explant and replace a valve, the most common of which is regurgitation.These complications can have many root causes, including but not limited to patient factors, (age, disease states, comorbidities), pharmacological factors, or procedure factors.It is typically not related to product malfunction.Although there are multiple root causes, valves are typically explanted because they are not functioning optimally.In this case, it was reported that there was pannus formation on the explanted device.Without additional information from the health care provider or return of the device for evaluation, we are unable to confirm the clinical comments made or determine the root cause for this event.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 information through literature review of "starr-edwards aortic valve: forty-four years old and still working", author: kevin l.Greason et al, published in the american association for thoracic surgery, volume 146, number 4, pages e21 - e22.Edwards received information that a (b)(6) man patient had an explant of starr-edwards aortic valve due to moderate prosthetic valvular regurgitation after an implant period of approximately fourty-four (44) years.Examination of this valve indicated a mild degree of pannus growth over the sewing ring of the prosthetic valve with no major structural valve deterioration.This valve was replaced with a composite valve conduit of a 25mm carbomedics top-hat valve (sorin) and 30mm polyester graft.There was no bleeding or thromboembolic complication related to the patient's aortic valve.Patient was discharged on post-operative day number 5.Patient was in nyha class ii at 5 weeks of follow up with a normally functioning prosthetic valve.

• Brand Name: STARR-EDWARDS¿ SILASTIC BALL HEART VALVE PROSTHESIS
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; mle-8; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5181896
• MDR Text Key: 29409998
• Report Number: 2015691-2015-02879
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P870038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2015
• 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: 66 YR