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

Model Number 11500A25

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned to edwards for evaluation.Attempts to retrieve the device and additional information are in process.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.Based on the information received the cause of the event cannot be determined.No further corrective or preventative actions are required at this time.Edwards lifesciences will continue to monitor all reported events.

Event Description

It was reported via patient registry that a 25mm aortic valve was explanted and replaced with a 23mm after an implant duration of 2 months due to unknown reasons.

Manufacturer Narrative

H10.Additional manufacturer narrative: edwards received additional information through follow up with the healthcare provider.There may be cases in which our devices are implanted in a patient with active native valve or prosthetic valve/ring endocarditis.In these cases, it is not unusual to have a recurrence of endocarditis that results either in death or removal of the newly implanted edwards device.When this occurs, the organisms causing the endocarditis were never completely eliminated; therefore, the event is not related to the newly implanted device.Based on the available information, the root cause of the event was likely due to patient related factors and the progression of the patient's underlying valvular disease pathology.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency and/or one was not confirmed through investigation.In addition, the event does not allege a labeling issue or device related infection; therefore, no dhr is required.A lot history review was performed, and no events with the same defect were found.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

It was reported via patient registry that a 25mm aortic valve was explanted and replaced with a 23mm after an implant duration of 2 months and 27 days due to chronic recurrent subacute bacterial endocarditis.The patient tolerated the procedure well and was returned to the intensive care unit in satisfactory condition.The patient was discharged in stable condition on post-operative day six.

• 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: 8967047
• MDR Text Key: 156718652
• Report Number: 2015691-2019-03330
• 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,stu
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2020
• Device Model Number: 11500A25
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR