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

Model Number 11500A19

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation: the valve was not returned for evaluation as it remains implanted.The green suture observed on the leaflet was returned for evaluation.Also, pictures of the green particulate on the valve at time of event were provided by customer.A green particulate approximately 1 mm long was returned.Green particulate appeared to be attached to the inflow surface of one of the valve leaflets in the photos provided.Udi number: (b)(4).Customer report of "green suture was attached to the leaflet on the inflow side" was confirmed through image 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.The cause of the event remains indeterminable.There were no patient complications.Further evaluation is being performed.A supplemental mdr will be submitted as new information is received.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

Edwards received information that a green suture was attached to the leaflet on the inflow side of the 19 mm aortic pericardial valve when the device was removed from the tray before use.The green material was removed and the device was used.The device will not be returned for evaluation as it remains implanted; however, suture to be returned.There were no patient complications reported.

Manufacturer Narrative

H10.Additional manufacturer narrative: the green fragment is confirmed to be green monofilament thread that is used to attach id tag to the valve and valve holders to the valve.Since the id tag has already been cut from the valve by customer, it cannot be confirmed that the green monofilament fragment came from manufacturing.Also, there are multiple inspection and fiber removal steps along the assembly process of the inspiris valve in final assembly cleanroom and resilia cleanroom.This fragment in question can be seen with unaided eyes and is unlikely to have passed the multiple inspection steps at edwards.The dhr was performed and no related nonconformances were found.It is possible that the green fragment was generated when the customer cut the id tag.However, a definitive root cause could not be conclusively determined.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9468225
• MDR Text Key: 188704155
• Report Number: 2015691-2019-04652
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150048/S021
• 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: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: 11500A19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR