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

Model Number 11500A

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

Udi number: (b)(4); additional manufacturer narrative: the device was not returned to edwards for evaluation.Attempts to retrieve 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.If additional information is received a supplemental mdr will be submitted.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 during the initial implant of a 27mm inspiris valve, the physician had difficulty seating the valve.There was a concern the sizer was not an accurate representation for the 27mm valve.The physician sized the patient with an edwards sizing kit.The physician used the replica end of a 27mm sizer which fit the patient.When the 27mm valve was placed in the annulus, the valve would not fit, it was too big.The physician had to remove the valve from the holder and handle to manually place the device.The physician stated the valve seemed about 2mm off from the replica sizer.The physician had to maneuver the valve into place.Echo showed good seating of the valve with no leaks post procedure.Additionally, the physician placed a valsalva tubular graft to address the patients' aortic aneurysm.The patient was not impacted by the manual placement of the valve.

Manufacturer Narrative

H10.Additional manufacturer narrative: added h6 codes.The physician stated the inspiris valve seemed about 2mm off from the replica magna ease sizer.No product was returned for evaluation.As no product, images, or medical records were returned, the complaint is unable to be confirmed and a definitive root cause cannot be conclusively determined.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10469238
• MDR Text Key: 205349933
• Report Number: 2015691-2020-13371
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1