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

Model Number 11500A

Device Problem Break (1069)

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

Event Date 04/06/2023

Event Type  malfunction  

Event Description

Edwards received notification that the holder of this inspiris valve model 11500a25 broke at some moment during parachuting the valve into position causing the valve to get distorted, which made the implantation difficult.As reported, after piercing the sutures through the ring, part of the plastic retainer broke and buckled as it went down to the aortic annulus.However, implantation was still possible, but it was just a bit more difficult.No force was exerted on the holder.No damage was observed in the holder before it broke.No harm resulted for the patient from the rupture of the valve holder.The patient's postoperative course was unremarkable and the valve presented with an excellent result in the control echo.

Manufacturer Narrative

H3: device evaluation: the device was returned for evaluation.Customer report of broken valve holder was confirmed.As received, one of the three legs of the valve holder was broken off with jagged edge at the end.The holder leg appeared to match up with holder.All three green sutures were cut at the cutting channels and each were approximately 3 cm in length.Valve was not returned.Three customer photos were also reviewed.Lab findings were consistent with customer photos.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

Added information to section d4 (expiration date), h4 (device manufacturer date), h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions) h10: additional manufacturer narrative: a dhr review was performed, and no related manufacturing nonconformances were identified.The holder lots related to the subject device passed incoming sampling inspections for molding defects and gross abnormalities.Lot history review and complaint history review did not identify any similar events for the same component lot numbers.Therefore, there is no evidence to support that a supplier manufacturing issue caused the reported event.Significant force is not applied to the valve holder during assembly, and it is unlikely that an edwards manufacturing error contributed to the reported holder breakage.It is possible that the breakage was caused by handling of the device, however, as reported, no excessive force was applied to the holder, and based on the reported information, there is no evidence that a customer handling error contributed to the reported event.Based on the information available, a definitive root cause is unable to be determined at this time.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2 office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17102106
• MDR Text Key: 317077430
• Report Number: 2015691-2023-13596
• Device Sequence Number: 1
• Product Code: LWR
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2023
• 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
• Date Returned to Manufacturer: 05/17/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2022
• 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