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

Model Number 6120T

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Calcium Deposits/Calcification (1758); Mitral Valve Stenosis (1965)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Host fibrous (pannus) tissue growth is expected in all prosthetic/bioprosthetic heart valves and 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 in bioprosthetic heart valves.The root cause of this event cannot be confirmed; however, it is likely that patient related factors contributed to this event.There was no indication or allegation of a product malfunction.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

Through review of the literature article: "explant of a ball and cage valve 42 years after initial implant," authors vincent chan et al, it was learnt that this mechanical mitral valve model 6120t was explanted after an implant duration of approximately 42 years due to pannus and mitral annular calcification.As reported, the patient presented with dyspnea and fatigue.Transthoracic echocardiography showed mildly elevated transprosthesis gradients, with early-onset pulmonary hypertension, tricuspid regurgitation, and right heart dysfunction.Mitral valve re-replacement was recommended.During explant, extensive pannus formation was observed extending into the mitral orifice from the valve¿s sewing ring.The patient also had extensive mitral annular calcification.This annular calcification, along with the pannus, was debrided, and the starr¿edwards valve was removed.The annulus was reconstructed, the valve was re-replaced with a non edwards 25-mm valve, and a biatrial cryomaze and concomitant tricuspid repair was also performed.The postoperative echocardiogram showed no evidence of perivalvular leak and a mean transprosthesis gradient of 2 mmhg.The patient had an uneventful postoperative course and was discharged on postoperative day 9 without event.One year after surgery, the patient remained asymptomatic without functional limitations or evidence of hemorrhagic or thromboembolic events.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• 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
• MDR Report Key: 7671348
• MDR Text Key: 113516152
• Report Number: 2015691-2018-02702
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P870038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6120T
• 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; Required Intervention