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

Model Number 11500A

Device Problems Nonstandard Device (1420); Detachment of Device or Device Component (2907)

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

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: the subject device is not available for evaluation.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.

Event Description

Edwards received notification that this inspiris resilia valve model 11500a23 was found to have "an abnormal thread".As reported, "there was a detachment of the dacron (polyester) knit at the level of the prosthesis valve." reportedly, the valve was not used.The issue was observed at the sewing of the 2.0 ticron stitches.No other information was provided.

Manufacturer Narrative

H10: additional manufacturer narrative: the device history record (dhr) review was completed, and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.The root cause of the reported loose thread is related to the design of the product/stent assembly.The root cause is not related to the valve implant procedure or a manufacturing non-conformance.Updated d4, h4, h6.

Manufacturer Narrative

H10: additional manufacturer narrative: updated b5.H11: corrected data: based on the additional information obtained, this event is no longer considered reportable, and this correction is being submitted.

Event Description

Edwards received notification that this inspiris resilia valve model 11500a23 was found to have "an abnormal thread".As reported, "there was a detachment of the dacron (polyester) knit of one single stitch at the level of the prosthesis valve." reportedly, the valve was not used.The issue was observed at the sewing of the 2.0 ticron stitches.In this case the loose thread was discovered prior to implant and the valve was not used.The device was returned for evaluation.Customer report of loose thread was confirmed.As received, a long white thread, approximately 83mm long, was found extending from the sewing ring around leaflet 2 near commissure 2 on the outflow aspect.The loose white thread was pulled during evaluation and would not come detached from the sewing ring.

Event Description

Edwards received notification that this inspiris resilia valve model 11500a23 was found to have "an abnormal thread".As reported, "there was a detachment of the dacron (polyester) knit of one single stitch at the level of the prosthesis valve." reportedly, the valve was not used.The issue was observed at the sewing of the 2.0 ticron stitches.The device was returned for evaluation.Customer report of loose thread was confirmed.As received, a long white thread, approximately 83mm long, was found extending from the sewing ring around leaflet 2 near commissure 2 on the outflow aspect.The loose white thread was pulled during evaluation and would not come detached from the sewing ring.

Manufacturer Narrative

H10: additional manufacturer narrative: updated b5.

• 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 LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: gail warner ; 1 edwards way; mailstop ant 6.1; irvine, CA 92614 ; 9492504096
• MDR Report Key: 12637398
• MDR Text Key: 276674114
• Report Number: 2015691-2021-05671
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194982
• UDI-Public: 00690103194982
• 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,Followup,Followup
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• 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: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2021
• 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): Life Threatening