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

Model Number 11500A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Great Vessel Perforation (2152)

Event Date 10/06/2021

Event Type  Injury  

Event Description

Edwards received information a 23mm 11500a aortic valve was explanted at implant due to sizing.It was reported the surgeon went to implant the 23mm 11500a and had difficulty passing the valve into the annulus.Medical records noted as the 23mm 11500a was passing through the sinotubular junction, the aorta tore.The aorta was noted to be very friable.The 23mm valve was removed and replaced with a 21mm 11500a aortic valve as surgeon was concerned about further disruption of the sinus.Device is available for return.Patient did well.The patient remained intubated and was transferred to the cv recovery unit.Patient was discharged home in stable condition on post-operative day eight (8).

Manufacturer Narrative

As received, valve was still attached to holder with all three green sutures intact at the cutting channels.The x-ray demonstrated the wireform and cocr band remained intact; the vfit cocr alloy band was not expanded.No visible inconsistencies were observed on the valve.Suture holes were observed around the sewing ring.The device was returned for evaluation.Customer report of sizing issues could not be confirmed through visual observations.A supplemental mdr will be submitted as soon as additional information becomes available.The cause of the event cannot be determined at this time.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.

Manufacturer Narrative

H3.Device evaluation: the external sewing ring diameter measured to be approximately 29 mm and the internal stent diameter measured to be approximately 22 mm.The device history record was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.The cause of the event was most likely related to procedural factors.

Manufacturer Narrative

H10.Additional manufacturer narrative: measurements performed in product evaluation align with nominal measurements provided in the ifu.

• 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: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 12791673
• MDR Text Key: 283680530
• Report Number: 2015691-2021-06248
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 11/10/2021
• Supplement Dates Manufacturer Received: 01/05/2022; 01/12/2022
• Supplement Dates FDA Received: 01/05/2022; 01/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 83 KG