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

Model Number 11500A

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

Product evaluation: customer complaint of contamination issue was confirmed.As received, the valve was still attached to the holder.As received, blue fibrous material was found on the outflow aspect of leaflet 2.During evaluation, the fibrous material moved from the free margin of leaflet 2 to leaflet 1 and remained attached.The fibrous material was measured to be approximately 2mm long.Suture holes were visible around the sewing ring.Ir spectrum of the unknown blue fibrous material showed similar absorption characteristics when comparing to cellulose like material.The device was returned to edwards for evaluation.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.A manufacturing related issue was not identified.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

It was reported while surgeon was using a 25mm aortic valve, he noticed something on the leaflet while he was placing sutures in the sewing cuff.He was unsure what it was, possibly a hole or defect, so he removed the sutures put in the sewing cuff.Device never touched the patient.Replacement device was another 25mm aortic valve.During product evaluation, blue fibrous material was found on the outflow aspect of leaflet 2.The material had similar absorption characteristics to cellulose like material.

Manufacturer Narrative

Corrected data: reference (b)(4).

• 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: 8544413
• MDR Text Key: 143891669
• Report Number: 2015691-2019-01431
• 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
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2021
• Device Model Number: 11500A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR