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

Model Number 11500A19

Device Problems Material Discolored (1170); Contamination /Decontamination Problem (2895)

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

Event Date 08/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The explanted valve has been returned for evaluation; however, the analysis is still in progress.A supplemental report will be submitted accordingly once the product evaluation has been completed.

Event Description

It was reported that prior to use of the 29mm pericardial aortic valve, a spot (dark in color) was observed on one of the leaflets by a nurse.It did not wash off with saline.The valve never made contact with any patient.

Manufacturer Narrative

Customer report of "spot (dark in color) was seen on one of the leaflets" was confirmed.As received, dark fibers were observed on the inflow aspect of leaflet 2.Multiple black fibers measuring approximately 1mm in length were found on the inflow aspect of leaflet 2.The fibers were sent to chemistry for analysis.The valve remained attached to the holder, suture holes were not visible on the sewing ring, and the id tag was returned detached from the valve.X-ray demonstrated the wireform intact.As received the shelf box appeared to have been crushed, and did not appear in the same condition as in the image provided by the customer.The tagalert had black-highlight with the number 2 displayed on the screen.Tagalert serial number (b)(4).Triggered day is unknown; the shelf box and tagalert were disposed of during decontamination.Per chemistry analysis, ir spectrum of the unknown fiber showed similar absorption characteristics when comparing to cellophane like material.It is standard of care and prescribed in the ifu that valves and patches undergo a series of extensive rinses during the preparation phase prior to implant in the patient.This rinse process is required as the valves and patches are stored in glutaraldehyde.Accessories are also typically rinsed prior to use.It is possible, during this standard / mandatory device preparation, fibers or particulate maybe observed.There are inherent tissue fibers on the ¿rough¿ surface of the pericardial tissue that at times can be difficult to distinguish from particulate.The rinse process should remove all particulate.As a result, small amounts of particulate are highly unlikely to enter the patient and cause injury.There are cases, however, where the particulate can be partially embedded in or attached to the leaflet or valve.If the particulate can be rinsed, the potential for injury to the patient is remote.If the particulate could be not removed during the rinsing process, and the valve was used in a patient, there is a potential for the particulate to enter the patient and embolize.In this case, the origin of the 1mm cellophane like particulates could not be conclusively determined.It is possible that the particulates contacted the valve after its jar was opened by the customer.A manufacturing defect was not confirmed.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Per the instructions for use (ifu), the user is advised to "avoid contact of the leaflet tissue or the rinse solution with towels, linens, or other sources of lint and particulate matter that may be transferred to the leaflet tissue." 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.

Manufacturer Narrative

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

• 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: 7961667
• MDR Text Key: 123820138
• Report Number: 2015691-2018-04186
• 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,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2019
• Device Model Number: 11500A19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1