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

Model Number 11500A

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/08/2023

Event Type  malfunction  

Event Description

It was reported that the scrub nurse noticed a defect in the valve where it didn't just have a gap in the center but also between the leaflets.The surgeon was concerned about the gap in the leaflet and not sure if they can trust it.No patient involvement.

Manufacturer Narrative

H10: additional manufacturer narrative: the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.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

Product evaluation: the customer report of "gap in the center but also between the leaflets" was confirmed.As received, valve was still attached to holder with all three green sutures intact at the cutting channels.Leaflet 3 was slightly open but was able to be pushed back into closed position when probed.The x-ray demonstrated the wireform and cocr band remained intact; the vfit cocr alloy band was not expanded.Suture holes were not visible around the sewing ring.No other visible inconsistencies were observed on the valve.

Manufacturer Narrative

Updated sections: g3, g6, h2, h6 (component code, type of investigation, investigation findings, and investigation conclusions).Root cause analysis: per event description, "it was reported that the scrub nurse noticed a defect in the valve where it didn't just have a gap in the center but also between the leaflets.The surgeon was concerned about the gap in the leaflet and not sure if they can trust it.No patient involvement." two color images were provided, one of the valve packaging and one showing an inflow view of the subject device, confirming the reported gap between leaflets one and three.The device was returned and per product evaluation, "customer report of "gap in the center but also between the leaflets" was confirmed.As received, valve was still attached to holder with all three green sutures intact at the cutting channels.Leaflet 3 was slightly open but was able to be pushed back into closed position when probed.The x-ray demonstrated the wireform and cocr band remained intact; the vfit cocr alloy band was not expanded.Suture holes were not visible around the sewing ring.No other visible inconsistencies were observed on the valve." dhr review was performed, and no relevant non-conformances were identified and the valve passed flow and coaptation testing during production.The provided image of the valve also shows discoloration between leaflets one and three which could potentially be blood transferred from touching the leaflet.It is possible the gap between the leaflets was created or exacerbated by probing.The complaint is confirmed, however, a definitive root cause cannot be conclusively determined based on the information available and an edwards defect cannot be confirmed.

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17664207
• MDR Text Key: 322431167
• Report Number: 2015691-2023-15611
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194999
• UDI-Public: (01)00690103194999(17)270327(11)2303282110131588
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11500A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other