MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS; TISSUE, HEART-VALVE

Model Number 11500A

Device Problems Perivalvular Leak (1457); Appropriate Term/Code Not Available (3191)

Patient Problems Arrhythmia (1721); No Code Available (3191)

Event Date 09/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned to edwards for evaluation as it was discarded.The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.Regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bioprosthetic sewing ring and the annulus.While the majority of affected patients are asymptomatic, it can lead to significant morbidity including heart failure and hemolytic anemia.Pvl can occur in the mitral and aortic position for similar reasons, including technique and patient related factors.The type and cause of regurgitation varies depending upon multiple factors.Typically, mild regurgitation is not unusual after initial valve replacement, and is usually tolerated by patients.Often moderate to high regurgitation requiring re-operation in the immediate post-operation period is due to procedural related issues and is unrelated to the device.Regurgitation which develops progressively over time can be due to number of issues including patient related factors or structural valve deterioration.A definitive root cause could not be determined.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

Edwards learned that a 23mm valve implanted for 11 days, was explanted to repair a pvl and ventricular septal defect; another 23mm valve was implanted.The patient tolerated the procedure well.The patient was released home in stable condition on pod #7 (second avr).Per received records, a patient with a history of ivdu, was admitted for acute pulmonary edema/chf due to native valve endocarditis, aortic insufficiency, and stenosis with vegetations.An avr and aorto-rv fistula patch repair was successfully performed.One week post implant, a murmur was detected; a new pvl and a ventricular septal defect was present.Eleven days post the index procedure, an avr redo along with a vsd patch repair was successfully performed.The vsd measured about 2x2 mm and was located directly underneath the septal leaflet of the tricuspid valve.The post-operative course was complicated by a sick sinus rhythm; a permanent pacemaker was placed on pod#4.There were no further complications and the patient was eventually discharged although there was a residual, insignificant vsd.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10045293
• MDR Text Key: 191409022
• Report Number: 2015691-2020-11829
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 11500A
• 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
• Patient Age: 44 YR
• Patient Weight: 56