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

Model Number 11500A

Device Problems Gradient Increase (1270); Patient Device Interaction Problem (4001)

Patient Problems Dyspnea (1816); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2021

Event Type  Injury  

Manufacturer Narrative

H10: additional manufacturer narrative: stenosis, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient-related contributing factors.Structural valve deterioration (svd) is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes, occurring singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, non-structural valve dysfunction (nsvd) may also play a role in the development of valvular stenosis.Stenosis is most commonly related to patient factors and is not usually an indication of a device malfunction.The root cause of this event was determined to be due to procedural related factors, including size of the valve implanted.The subject device is not available for evaluation as it remains implanted in the patient.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.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 via the patient support center by the patient that his 19mm 11500a aortic valve exhibited increased gradient 20mmhg, 3 months post procedure.Gradients continued to increase over the next 6 months and now at 40mmhg.He was on eliquis and then was switch to coumadin.He was told the valve appears to be working fine, but gradients continue to rise.Arteriogram is scheduled for september to check for any blockage that could be contributing to the increasing gradients.Through investigation, echo obtained showed severe aortic stenosis with plans for redo avr with root enlargement.Per medical records from initial surgery, the patient underwent right mini-thoracotomy avr due to severe native aortic stenosis.Intraoperatively the valve was found tri-leaflet with severe stenosis.The valve was excised and 19mm 11500a was implanted with 14 subannular sutures, the valve seated in place nicely and was secured with cor-knot device.After weaning from bypass tee demonstrated the valve functioned and no pvl.The patient tolerated the procedure and discharged on pod #3.Two year post-op cardiologist visit, states patient was treated for halt with eliquis and subsequently warfarin due to increasing aortic gradient with no improvement.Echo shows severe bioprosthetic stenosis with mean gradient of 62mmhg, leaflet do appear to open but no room for even minor changes given his very small aortic root and very small valve.Patient is asymptomatic at this time.Plan for redo avr and root enlargement tentatively in 2-3 months.

Manufacturer Narrative

Updated sections b5, b7, h6 (health effect - impact code, type of investigation).

Event Description

The patient underwent redo avr and aortic root enlargement after an implant duration of 2 years due to patient prosthesis mismatch and severe stenosis.The patient feels relatively well with ability to do activities without significant shortness of breath.The explanted valve was replaced with a 25mm 11500a valve.Per medical records, the 19mm 11500a valve showed no evidence of structural valve deterioration.There was no calcification, thickening, or stiffening of the leaflets.The increased gradients appear to be primarily secondary to patient prosthesis mismatch.The previous 19mm valve was removed and the annulus was debrided.The annulus was sized and it accommodated a 25mm valve, but the sinuses of valsalva and sinotubular junction would not.Therefore, a root enlargement was performed in order to be able to use a 25mm valve.An 18mm dacron graft was cut to fit and sewn in place.The sizers were used again to size the annulus which was much larger and able to accommodate the appropriate valve.The 25mm 11500a valve was implanted and appeared to be well-seated.The patient was separated from bypass and protamine was administered.Hemostasis was achieved.Per pathology report, there was no discrete masses, vegetations, or nodular calcifications were identified.

Manufacturer Narrative

H10: additional manufacturer narrative: updated section h6 (device code).H10: corrected data: corrected section h6 (component code, health effect - clinical code, investigation findings, investigation conclusions), h10 (additional manufacturer narrative) patient prosthesis mismatch (ppm) is present when the effective orifice area of the inserted prosthetic valve is too small in relation to body size.Its main hemodynamic consequence is to generate higher than expected gradients through a normally functioning prosthetic valve.The root cause of this event cannot be conclusively determined with the available information.However, the event in this case was likely impacted by procedural related factors.There is no allegation of a malfunction which could be related to a manufacturing non-conformance; no labeling non-conformance/deficiency; no use-related issue with a hazardous situation; no device-related infection; and there is no evidence of a product failure with regard to design, reliability, or use error.The subject device was discarded.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.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

Per medical records, the patient presented with shortness of breath and underwent redo avr with root enlargement with 18mm dacron graft, ascending aortoplasty for supravalvular stenosis, resection of subvalvular tissue, and laa-clip.Intraoperatively the 19mm 11500a valve showed no evidence of structural valve deterioration.There was no calcification, thickening, or stiffening of the leaflets.The increased gradients appear to be primarily secondary to patient prosthesis mismatch.The previous 19mm valve was removed and the annulus was debrided.A root enlargement was performed in order implant a 25mm 11500a , the valve appeared well-seated and was secured with cor-knots.The patient was separated from bypass, after hemostasis was achieved was transferred to the icu.On pod #1, patient was hemodynamically stable and overall great results thus far.

• Brand Name: 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 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: 18057033
• MDR Text Key: 327185395
• Report Number: 2015691-2023-17203
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194968
• UDI-Public: (01)00690103194968(17)230228(11)190301216268904
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2019
• 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; Life Threatening
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 88 KG