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 11/06/2023

Event Type  Injury  

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 4cm in length.Valve was not returned.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 events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received notification that by pushing a valve model 11500a27 for parachuting into the annulus one arm of the holder broke.The patient did not suffer any injury or adverse event due to this issue.A broken piece fell into the patient but was removed.No other intervention was needed to retrieve any broken piece inside the patient.The valve and the holder were inspected before use and no damage was observed.Reusable handle model 1111 was use.The valve was successfully implanted and the patient was doing well.

Manufacturer Narrative

Added information to section d4 (expiration date) and h4 (device manufacturer date) updated section b4 (date of this report), g3 (date received by manufacturer), h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions).H10: additional manufacturer narrative: per product 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 4cm in length.Valve was not returned.A photograph of the device was provided by the customer, which was consistent with the product evaluation findings.A dhr review was performed, and no related manufacturing nonconformances were identified.The holder lot related to the subject device passed incoming sampling inspections for molding defects and gross abnormalities.A lot history review identified one additional complaint associated with the same supplier finished goods lot.However, this complaint was associated with a different component material lot number and edwards receiving inspection lot when compared to the subject complaint.Therefore, there is no indication that the reported event was the result of a supplier manufacturing error based on the lot history review.It is possible that the breakage was caused by handling of the device, however, no information was provided suggesting 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: 18299457
• MDR Text Key: 330111456
• Report Number: 2015691-2023-18257
• 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: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2023
• 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