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

Model Number 11500A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis (2100); Thrombus (2101)

Event Date 11/27/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it was discarded.The device history record (dhr) was unable to be reviewed as the device serial number was not provided.Valve thrombosis is the formation of significant blood clots forming on the valve.Valve thrombosis is a rare and well-recognized complication of prosthetic valves.These clots could significantly impact the functionality of the valve resulting in heart failure or thromboembolism.Immediate intervention, either by thrombolytic therapy or valve replacement is required for significant thrombosis.Alternatively, there may be cases where the patient is placed on an anticoagulant to treat thrombosis.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 received notification that this valve was explanted due to thrombosis.On transthoracic echo, it was observed a large thrombus on the right coronary sinus after an implant duration of 11 days.Initially the patient was treated with anti-coagulation and a control tee was performed.The valve was explanted and it was reported to be in perfect condition.Thrombus was removed and another valve was implanted in replacement.

Manufacturer Narrative

Updated sections d4 and h4.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.

Event Description

Edwards received notification that this 21mm valve was explanted due to thrombosis.On transthoracic echo, it was observed a large thrombus on the right coronary sinus after an implant duration of 11 days.Initially the patient was treated with anti-coagulation and a control tee was performed.The valve was explanted 1 month and 3 days since the implant and it was reported to be in perfect conditions.Thrombus was removed and another inspiris valve of the same size was implanted in replacement.Patient was doing well.

Manufacturer Narrative

H10.Additional manufacturer narrative: updated sections b5, d6, and d7.

Manufacturer Narrative

Corrected data: f10, h6.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: 9504981
• MDR Text Key: 176416705
• Report Number: 2015691-2019-04807
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/28/2019

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: 03/18/2021
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/28/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 12/18/2019; 01/22/2020; 07/23/2020
• Supplement Dates FDA Received: 01/08/2020; 01/24/2020; 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention