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

Model Number 11500A

Device Problems Gradient Increase (1270); Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001); Thickening of Material (4056)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Type  Injury  

Event Description

Edwards received notification that a valve model 11500a implanted in the aortic position was explanted due to severe gradient (peak 100mg, mean 61mmhg) observed on tte and confirmed on toe with values in keeping with severe aortic stenosis after approximately one (1) year of implant duration.The leaflet appeared thickened and immobile.No vegetations or obvious thrombus was seen.On explant, seemed that the leaflets became fibrotic.Before the explant procedure, the patient presented with nyha ii, normal sinus rhythm and was recommend continuing with anticoagulation.It was decided to explant the 11500a valve and a mechanical valve was implanted in replacement.The patient was hospitalized in stable condition.

Manufacturer Narrative

H10.Additional manufacturer narrative: the device was 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 events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

Updated section b4 (date of this report), b5 (describe event or problem), b7 (additional text), d6 (implant date), d6 (explant date), d9 (device availability), d9 (date returned to manufacturer), g3 (date received by manufacturer), h6 (device code).H3: product evaluation: the device was returned for evaluation.Customer report of pannus, stenosis, immobile leaflets and fibrotic leaflets was confirmed.Vegetation was observed on both the inflow and outflow surfaces of all three leaflets.Heavy host tissue overgrowth (pannus) encroached onto the tissue and into the orifice at the greatest distance of approximately 6 mm on leaflet 1 at the inflow aspect.Moderate host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 1 mm on leaflet 1 and over all three stent posts at the outflow aspect.Vegetation and host tissue overgrowth restricted leaflet mobility and led to stenosis.Host tissue overgrowth on the stent circumference was moderate at the outflow aspect.Sewing ring was cut off all around the valve except in an area around leaflet 2 near commisure 2 where a suture thread remained attached.Cut off sewing ring fragment was not returned with valve.Metal band was exposed all around the valve at the inflow aspect.The x-ray demonstrated the wireform and cocr band remained intact; the vfit cocr alloy band was not expanded.Nine customer photos were also reviewed.The returned valve was consistent with customer photos showing different views of an explanted valve.Customer photos also shown a valve implanted consistent with the returned valve.Further investigations are under way in relation to the vegetation findings in this product 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.

Event Description

Edwards received notification that a valve model 11500a implanted in the aortic position was explanted after an implant duration of one (1) year and three (3) months due to pannus leading to severe gradient (peak 100mg, mean 61mmhg) observed on tte and confirmed on toe with values in keeping with severe aortic stenosis.The leaflet appeared thickened and immobile.No vegetations or obvious thrombus was seen.On explant, seemed that the leaflets became fibrotic.Before the explant procedure, the patient presented with nyha ii, normal sinus rhythm and was recommend continuing with anticoagulation.It was decided to explant the 11500a valve and a mechanical valve was implanted in replacement.The patient was currently doing well clinically however, suffers from anxiety and depression.The patient was not using the anticoagulant medication correctly.

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.Based on further review of the product evaluation, the "fibrotic leaflets" were removed form the findings.The evaluation summary is therefore updated to: customer report of pannus, stenosis and immobile leaflets was confirmed.Vegetation was observed on both the inflow and outflow surfaces of all three leaflets.Heavy host tissue overgrowth (pannus) encroached onto the tissue and into the orifice at the greatest distance of approximately 6 mm on leaflet 1 at the inflow aspect.Moderate host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 1 mm on leaflet 1 and over all three stent posts at the outflow aspect.Vegetation and host tissue overgrowth restricted leaflet mobility and led to stenosis.Host tissue overgrowth on the stent circumference was moderate at the outflow aspect.Sewing ring was cut off all around the valve except in an area around leaflet 2 near commisure 2 where a suture thread remained attached.Cut off sewing ring fragment was not returned with valve.Metal band was exposed all around the valve at the inflow aspect.The x-ray demonstrated the wireform and cocr band remained intact; the vfit cocr alloy band was not expanded.Nine customer photos were also reviewed.The returned valve was consistent with customer photos showing different views of an explanted valve.Customer photos also shown a valve implanted consistent with the returned valve.Pannus overgrowth, or host tissue, is considered to be a form of non-structural valve dysfunction.The growth of host tissue on the sewing ring is expected and is a natural part of the healing reaction to prosthesis implantation.A small amount of host tissue growth over the suture line is needed to form a non-thrombogenic surface and complete the healing process after valve implantation.In contrast, if there is an excessive amount of pannus growth, it can extend onto the cusp surfaces leading to thickening of the cusps, leaflet immobility, elevated gradients, and stenosis.Host tissue growth can also contribute to cusp retraction or curling resulting in valvular regurgitation.Host fibrous (pannus) tissue growth is not a malfunction of the device.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.The most likely cause is patient factors.Intermediate, or late endocarditis (greater than 60 days post-implant) occurs due to the implant being seeded from an infection or microbial contamination from elsewhere in the patients body and is not in any way related to the sterilization or packaging process of the device.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.The most likely cause is patient factors.

Event Description

Edwards received notification that a valve model 11500a23 implanted in the aortic position was explanted after an implant duration of one (1) year and three (3) months due to pannus leading to severe gradient (peak 100mg, mean 61mmhg) observed on tte and confirmed on toe with values in keeping with severe aortic stenosis.The leaflet appeared thickened and immobile.No vegetations or obvious thrombus was seen.The patient did not receive treatment nor did have symptoms of endocarditis before the explant.Panbacterial and panfungal pcr tests were both negative for active infection of the subject device.On explant, seemed that the leaflets became fibrotic, pending to be confirmed.Before the explant procedure, the patient presented with nyha ii, normal sinus rhythm and was recommend continuing with anticoagulation.It was decided to explant the 11500a valve and a 21mm non-edwards mechanical valve was implanted in replacement.The patient was currently doing well clinically however, suffers from anxiety and depression.

• 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: 17841999
• MDR Text Key: 324551254
• Report Number: 2015691-2023-16419
• 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,Followup
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 63 KG