MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INSPIRIS RESILIA AORTIC VALVE; TISSUE, HEART-VALVE

Model Number 11500A23

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 05/17/2019

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).Multiple requests for additional information and for product return have been performed.The healthcare provider has not returned the explanted valve or provided any additional information at this time.The root cause of this event cannot be determined with the available information.It is unknown if patient and/or procedure related factors may have caused or contributed to this event.There has been no allegation of a product malfunction.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.If any new information is received, a supplemental report will be submitted accordingly.

Event Description

Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional "customer complaint".The information reported may or may not be related to the edwards device.It was reported that a 23 mm pericardial aortic valve was explanted after an implant duration of six (6) months due to unknown reasons.The explanted valve was replaced with a 21 mm 11500a pericardial valve.The patient was reported to be in recovery post procedure.

Manufacturer Narrative

Corrected data: f10, h6.Reference (b)(4).

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8767725
• MDR Text Key: 150277578
• Report Number: 2015691-2019-02498
• 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,use
• Type of Report: Initial,Followup
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2020
• Device Model Number: 11500A23
• 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: 69 YR