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

Model Number 11500A23

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Dyspnea (1816); Insufficient Information (4580)

Event Date 03/26/2024

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported that a 23mm 11500a valve in the aortic position was explanted after an implant duration of 4 years, 11 months due to severe aortic regurgitation.The explanted valve was replaced with another 23mm 11500a valve.Upon explant there appeared to be leaflet perforation.

Manufacturer Narrative

H11: additional manufacturer narrative: updated: b4, b5, b7, d9, g3, g6, h2, h3, h6.H3: evaluation summary: report of regurgitation was unable to be confirmed in the as received condition.Leaflet perforation was confirmed.As received, all three leaflets had cuts of approximately 5mm x 8mm on leaflet 1, 10mm on leaflet 2, and 6mm x 10mm on leaflet 3.The cuts had a smooth and straight edge.Cutout leaflet fragments were not returned.Leaflet 1 had a non-transmural perforation of approximately 1mm x 1mm.The perforation was beveled at the outflow aspect.Sutures and fasteners remained on the sewing ring.X-ray demonstrated the wireform and cocr band remained intact and band was bent outward near leaflet 1; the vfit cocr alloy band was not expanded.Minimal calcification nodules on host tissue near leaflet 2 on the inflow aspect.Moderate host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 5mm on leaflet 3 on the inflow aspect.Minimal host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 1mm on leaflet 2 at the outflow aspect.Host tissue on the stent circumference was minimal at both the inflow and outflow aspects.As received, mechanical damage marks were observed on the cusp of all three leaflets near the commissures.Damages appeared serrated and did not penetrate leaflets.Sewing ring had multiple cuts around the valve and exposed metal band around leaflet 1 on the inflow aspect.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Event Description

It was reported that a 23mm 11500a valve in the aortic position was explanted after an implant duration of 4 years, 11 months due to leaflet perforation, severe aortic regurgitation and moderate stenosis.The patient presented with dyspnea on exertion.The explanted valve was replaced with another 23mm 11500a valve.Per medical records, preoperatively, tee demonstrated moderate to severe eccentric bioprosthetic valve regurgitation with possible degeneration of the posterior leaflet with poor coaptation at the leaflet tip.Intraoperatively, surgeon noted the previously placed pledgets were encased in scar and not visible.All old suture material was removed.Surgeon noted a stellate perforation of one of the leaflets.The leaflets were freely mobile and not calcified.The old valve was excised and another 23mm 11500a valve was sized.Surgeon had difficulty suturing the new 11500a valve noting that there was not enough strong tissue to hold the sutures to place the valve sutures any lower.The surgeon thought it would be ok.During sternal closure after weaning from bypass and decannulation, the right ventricle began to distend, and the patient became hypotensive.Surgeon suspected rca obstruction by the newly placed valve (2024-07823-02).Patient was quickly re-cannulated and went back on bypass.The left internal mammary artery was harvested as a free graft and a cabg was performed with some difficulty and surgeon noted good flow with better function of the right ventricle.On pod#2 patient returned to the or for sternum closure.On pod#14 patient was discharged.Per product evaluation, leaflet perforation was confirmed.As received, all three leaflets had cuts.The cuts had a smooth and straight edge.Moderate host tissue overgrowth encroached onto the tissue.

• Brand Name: EDWARDS 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 19144594
• MDR Text Key: 340613335
• Report Number: 2015691-2024-03018
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194982
• UDI-Public: (01)00690103194982(17)210108
• 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: 05/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female