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

Model Number 11500A

Device Problems Degraded (1153); Fluid/Blood Leak (1250); Gradient Increase (1270); Material Perforation (2205)

Patient Problems Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446)

Event Date 12/22/2023

Event Type  Injury  

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.

Event Description

It was reported and learned through medical records that a 23mm 11500a aortic valve in aortic position was explanted after an implant duration of two (2) years, seven (7) months and 8 days due to leaflet perforation, degeneration, moderate as and moderate ai, high gradient.The patient presented with sob in acute on chronic chf.The explanted valve was replaced with a mechanical valve.The patient was discharged on pod #5 in stable condition.Per medical records : preoperative ef 30 % and mean gradient 17mmhg with moderate aortic insufficiency.In or findings the valve leaflets appeared relatively normal with the exception of a leaflet perforation in the distal third of the right coronary cusp.There was normal pannus which was sent for micro.Post mechanical valve implant mean gradient 7mmhg and no ai.Pathology of explanted valve leaflets reveal granular appearance and one leaflet fenestration measuring 0.25cm.

Manufacturer Narrative

H10: additional manufacturer narrative: updated sections: b4, d4, g3, g6, h2, h4, h6 (type of investigation, investigation findings, and investigation conclusions).Product evaluation summary: customer reports of leaflet perforation and aortic insufficiency were confirmed through observed perforation due to suture tail abrasion.Reports of degeneration and "granular appearance" were unable to be confirmed through visual observations.The x-ray demonstrated commissure 2 wireform was bent outward and cocr band remained intact; the vfit cocr alloy band was not expanded.As received, a perforation was observed on leaflet 3.The perforation was beveled at the outflow aspect, a typical characteristic of those caused by suture tail/fastener abrasion.No sutures remained on the sewing ring of the valve.Minimal host tissue overgrowth was observed on the outflow stent circumference and encroached onto the tissue and into the orifice at the greatest distance of approximately 2mm on leaflet 3.Fibrin deposits were also observed on the surfaces of all three leaflets and valve stent circumference on both the inflow and outflow aspects.Sewing ring cloth was cut around leaflet 3.Engineering evaluation summary: complaint is able to be confirmed via product evaluation.There is no evidence to suggest an edwards manufacturing defect.Capa/scar/pra not required.Root cause analysis: per product evaluation, reports of degeneration and granular appearance were unable to be confirmed through visual observations.The x-ray demonstrated commissure 2 wire form was bent outward and cocr band remained intact; the vfit cocr alloy band was not expanded.As received, a perforation was observed on leaflet 3.The perforation was beveled at the outflow aspect, a typical characteristic of those caused by suture tail/fastener abrasion.A device history record (dhr) review was performed, and no relevant non-conformances were identified.Based on the provided information, the most likely cause is procedural factors, including suture tail abrasion which is considered use related as it is caused by the surgeon's suture placement and leaving the tails at a length and position where they contact the leaflet.An edwards defect has not been confirmed.All pertinent information available to edwards lifesciences has been submitted.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18565929
• MDR Text Key: 333508477
• Report Number: 2015691-2024-00544
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194982
• UDI-Public: (01)00690103194982(17)241028(11)201029217379044
• 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
• Report Date: 03/21/2024

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
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2020
• 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): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male