MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DUROMEDICS BILEAFLET HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 9120R

Device Problems Degraded (1153); Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Pannus (1447); Aortic Valve Stenosis (1717); Regurgitation (2259); Stenosis (2263)

Event Date 01/01/2001

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation.Attempts to retrieve additional information and return of the devices were unsuccessful.If additional information is received a supplemental mdr will be submitted.The device history record (dhr) reviews could not be performed as the serial number is unknown.Host tissue is a complex process triggered by the interaction between the host and the device and is highly variable among patients.Literature defines pannus as a type of scarring and tissue ingrowth.Based on the information received the cause cannot be determined; however, patient factors likely contributed to the 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

Article "clinical outcomes of repeat aortic valve replacement for subaortic pannus in mechanical aortic valve," circ j.2018; 82: 2535-2541 doi:10.1253/circj.Cj-18-0352 background: this study aimed to evaluate the early and late clinical outcomes after repeat aortic valve replacement (avr) for subaortic pannus in patients with mechanical valves.Methods and results: between 2001 and 2017, 51 patients (median age, 59 years; 42 women) with prosthetic aortic stenosis (as) caused by pannus ingrowth underwent repeat avr because of acute malfunction of monoleaflet valve (3 patients), severe prosthetic as (30 patients), and moderate prosthetic as at the time of tricuspid or mitral valve surgery (18 patients).The median follow-up duration was 100 (interquartile range, 64-138) months.Double valve replacement was performed in 45 (88%) patients.Median time interval from previous operation was 161 (interquartile range, 121-194) months.The explanted mechanical av was monoleaflet and bileaflet in 16 (31%) and 34 (67%) patients, respectively.Concomitant procedures included 16 mitral valve replacements (14 repeat) and 36 tricuspid valve surgeries (15 replacements, 21 repairs).No hospital deaths or cases of heart block occurred.Overall survival and event-free survival rates at 10 years were 88% and 51%, respectively.Late complications included recurrent prosthetic as (4 patients), new paravalvular leakage of the mitral valve (5 patients), and severe tricuspid regurgitation (2 patients).Conclusions: although repeat avr for subaortic pannus had acceptable early and late survival, recurrent prosthetic as was frequently observed during late follow-up.Three (3) mechanical valves model 9120r (duromedics valve, 1 sized 19mm and 2 sized 21mm) implanted in the aortic position were explanted due to subaortic pannus leading to aortic stenosis after an unknown exact implant duration.

Manufacturer Narrative

Based on the information received the cause was most likely due to patient factors and progression of underlying valvular disease pathology.

Manufacturer Narrative

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

• Brand Name: DUROMEDICS BILEAFLET HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9322726
• MDR Text Key: 166520921
• Report Number: 2015691-2019-04224
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P850006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9120R
• 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