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

Model Number 11500A

Device Problems Calcified (1077); Degraded (1153); Gradient Increase (1270); Patient-Device Incompatibility (2682); Difficult to Open or Close (2921)

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816); No Known Impact Or Consequence To Patient (2692)

Event Date 05/21/2020

Event Type  Injury  

Manufacturer Narrative

Bioprosthetic tissue valves can deteriorate with time and eventually fail contributing to regurgitation and/or stenosis.Structural valve deterioration (svd) is the most common reason for bioprosthesis explants and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.    in this case, a definitive root cause for early degeneration could not be conclusively determined with the available information.The subject device is not available for evaluation, as it remains implanted in the patient.The device history record (dhr) could not be reviewed, as the device serial number was not provided.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 information that increasing pressure gradient due to leaflet immobility was observed in the patient with a 21mm 11500aj aortic pericardial valve implanted for approximately one (1) year and three (3) months.The device was originally implanted for aortic valve replacement to correct aortic stenosis.The echo showed that the leaflet which corresponds to left coronary cusp and the leaflet which corresponds to non-coronary cusp were hardened, the leaflets were fused at the commissural area, and leaflet mobility was restricted.The customer felt that the leaflet hardening in one (1) year from the implant is early, and the customer has an impression of worse hemodynamics for inspiris valve than the magna ease valve.Redo-avr was planned.

Manufacturer Narrative

H11: corrected data: corrected section f10 (device code).

Manufacturer Narrative

Per internal md echo review: tte images from 3/2/2019 and 5/21/2020 reveal evidence of aortic bioprosthesis leaflet thickening and progressive prosthetic aortic stenosis.The bioprosthesis leaflet anatomy is better visualized on the echocardiogram of 5/21/2020, with apparent diffuse, hyperechoic thickening of the commissural edges and relatively symmetrically reduced systolic opening.The findings are suggestive of structural valve degeneration (svd).Although it is not stated which echocardiogram was performed 1 year and 3 months after aortic valve replacement, the timing is suggesting of premature svd.The early post-operative echo interval could be useful for comparison, and to assess whether there was any evidence of subclinical leaflet thrombosis that could have predisposed to early svd.

Event Description

Edwards received information that a 21mm 11500aj aortic pericardial valve implanted for approximately one (1) year and three (3) months developed prosthetic aortic valve stenosis with increased pressure gradient due to early valve deterioration, restricted leaflet mobility, and suspected patient-prosthesis mismatch.The device was originally implanted for aortic valve replacement to correct aortic stenosis.The echo showed that the leaflets corresponding to the left coronary and non-coronary cusps were hardened, and fused at the commissural area with restricted leaflet mobility.Dilatation of both atria and bilateral pleural effusion were also observed.  the customer felt it was early to observe leaflet hardening after an implant duration of one (1) year of the inspiris valve and the hemodynamics were inadequate compared to the magna ease valve.The patient has little subjective symptoms and is being followed up by the physician.

Manufacturer Narrative

H10: additional manufacturer narrative: per engineering evaluation, medical records indicate that patient prosthesis mismatch was suspected but not confirmed; image evaluation did not demonstrate patient prosthesis mismatch.Image analysis of the echocardiogram, as well as medical records, confirmed the stenosis, valve deterioration, and restricted leaflet mobility.Degeneration-related structural deterioration is most commonly related to patient factors and is not usually an indication of a device malfunction.H11: corrected data: corrected sections h6, h10 (additional manufacturer narrative).Bioprosthetic tissue valves can deteriorate with time and eventually fail contributing to regurgitation and/or stenosis.Structural valve deterioration (svd) is the most common reason for bioprosthesis explants and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.In this case, the reported event was confirmed by medical records and tte image analysis.Based on the available information and provided patient history, the early valve degeneration most likely resulted from patient factors.The subject device is not available for evaluation, as it remains implanted in the patient.The device history record (dhr) could not be reviewed, as the device serial number was not provided.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.

Manufacturer Narrative

H10.Additional narrative: updated sections a1 and b5.

Event Description

After an implant duration of approximately two (2) years, the patient underwent the valve-in-valve procedure due to severe aortic stenosis.A 23mm transcatheter valve was implanted in replacement.The patient status was reported as "recovered".The device was not returned for evaluation as it remained implanted.

Manufacturer Narrative

H10: additional narratives: updated b5 and h6 per new information received.

Event Description

Edwards received information that a 21mm 11500aj aortic pericardial valve implanted for approximately one (1) year and three (3) months developed prosthetic aortic valve stenosis with increased pressure gradient due to early valve deterioration, restricted leaflet mobility, and suspected patient-prosthesis mismatch.The device was originally implanted for aortic valve replacement to correct aortic stenosis.The echo showed that the leaflets corresponding to the left coronary and non-coronary cusps were hardened, and fused at the commissural area with restricted leaflet mobility.Dilatation of both atria and bilateral pleural effusion were also observed.The patient has little subjective symptoms and is being followed up by the physician.The device was not returned for the evaluation as it remained implanted.The echo images were provided for evaluation.The customer felt it was early to observe leaflet hardening after an implant duration of one (1) year of the inspiris valve and the hemodynamics were inadequate compared to the magna ease valve.The customer would like ew to evaluate the early valve deterioration.Patient medical history: end-stage renal failure on dialysis, iga nephropathy, paf s/p maze procedure/laa clipping, as s/p avr, multiple cerebral infarctions, bronchitis, asthma, meningioma, subacute right putaminal hemorrhage, acute pancreas inflammation, dyslipidemia, malignant lymphoma, cholelithiasis.After an implant duration of approximately two (2) years, the patient underwent the valve-in-valve procedure due to severe aortic stenosis.A 23mm sapien3 was implanted in replacement.The patient status was reported as "recovered".The device was not returned for evaluation as it remained implanted.Edwards obtained additional information from the literature article "bioprosthetic valve failure of the inspiris resilia valve during transcatheter valve implantation" cardiovascular intervention and therapeutics on (b)(6) 2023.The patient presented with dyspnea prior the valve-in-valve procedure.Computed tomography performed and revealed calcification in the leaflet of the device.The patient was discharged on pod #7 without complications.The author mentioned that the insufficient dilatation was observed during the valve-in-valve procedure, possibly due to calcification in the leaflet interfering with the expansion of the device's ring.

Manufacturer Narrative

H10: additional narratives: updated h6 per new information received.The most likely cause is patient factors, including end-stage renal failure on dialysis, iga nephropathy, and dyslipidemia.The device history record (dhr) was not able to be reviewed as the device serial number was not provided.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.

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: TISSUE, HEART-VALVE
• 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: amritha srinivasan ; 1 edwards way; mle-2; irvine, CA 92614 ; 9492504062
• MDR Report Key: 10517571
• MDR Text Key: 206487160
• Report Number: 2015691-2020-13497
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 03/24/2021

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 09/28/2020; 10/21/2020; 10/23/2020; 03/11/2021; 04/11/2023; 07/14/2023
• Supplement Dates FDA Received: 10/14/2020; 10/21/2020; 10/23/2020; 03/24/2021; 05/09/2023; 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 48 KG