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

Model Number 11500A

Device Problems Calcified (1077); Degraded (1153); Fluid/Blood Leak (1250); Gradient Increase (1270); Material Perforation (2205)

Patient Problems Presyncope (4410); Insufficient Information (4580)

Event Date 07/25/2023

Event Type  Injury  

Event Description

Edwards received notification that this 11500a25 valve implanted in aortic position was explanted from a 53 year old patient after an implant duration of 1 year due to degeneration leading to regurgitation and stenosis.A non-edwards mechanical valve was implanted in replacement.

Manufacturer Narrative

H10: additional manufacturer narrative: the product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.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.

Manufacturer Narrative

Added information to section a2 (date of birth), b5 (describe event or problem), b7 (other relevant history, including preexisting medical conditions (e.G allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)), d9 (date returned to manufacturer), h6 (health effect - clinical code) and h6 (type of investigation) h3: evaluation summary: customer report of degeneration leading to regurgitation and stenosis was confirmed.As received, all three leaflets had a blue-green tinged in color.The x-ray demonstrated the wireform and cocr band remained intact; the vfit cocr alloy band was not expanded.X-ray demonstrated heavy calcification on leaflet 1 and minimal calcification on leaflet 3.Extrinsic calcific deposits were observed on the surface of leaflet 1 and at the free margin of leaflet 3 near commissure 1 on the outflow aspect and on the surface of leaflet 1 near commissure 1 on the inflow aspect.Calcification restricted leaflet mobility and led to stenosis.Minimal host tissue overgrowth encroached onto the tissue and into the orifice on leaflet 2 and 1mm on leaflet 3 at the inflow aspect.A perforation was observed on leaflet 3.The perforation was beveled at the outflow aspect, a typical characteristic of those caused by suture tail abrasion.Leaflet perforation in the as received condition may contribute to regurgitation.As received, no sutures were attached to the sewing ring.Several non-transmural damages were also observed on leaflets 2 and 3 on the outflow aspect.Sewing ring cloth was cut around leaflet 2.Customer photos were aligned to lab findings although valve leaflets in customer photos did not appear to have a blue-green tinged color and extrinsic calcification deposits appear red tinged.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

Edwards received notification that this 53 years old patient with a 25mm inspiris resilia valve implanted in aortic position underwent a valve explant procedure after an implant duration of 1 year and 1 month due to degeneration leading to regurgitation and stenosis.The patient presented with pre-syncope.A non-edwards mechanical valve was successfully implanted in replacement.As reported, patient was noted as to be recovering.

Manufacturer Narrative

Added information to section d4 (expiration date) and h4 (device manufacturer date), h6 (device code(s)), h6 (type of investigation), h6 (investigation findings) and h6 (investigations conclusions) corrected data h6 (device code(s)): 1153 - degraded code removed.H3: evaluation summary and h10: additional manufacturer narrative: dhr review was performed and no relevant non-conformances were identified.The subject device was returned, however, no medical records or operative report were provided for evaluation.Per the product evaluation, customer report of "degeneration leading to regurgitation and stenosis was confirmed.X-ray demonstrated heavy calcification on leaflet 1 and minimal calcification on leaflet 3.Extrinsic calcific deposits were observed on the surface of leaflet 1 and at the free margin of leaflet 3 near commissure 1 on the outflow aspect and on the surface of leaflet 1 near commissure 1 on the inflow aspect.Calcification restricted leaflet mobility and led to stenosis.Minimal host tissue overgrowth encroached onto the tissue and into the orifice on leaflet 3 at the inflow aspect." product evaluation also identified a perforation on leaflet 3 that was beveled at the outflow aspect, a typical characteristic caused by suture tail abrasion.If the surgeon does not cut sutures close to the knot, excess suture tails may result in abrasion, perforation, or damage to the leaflet.This may require an exchange of the device.The ifu states, when using interrupted sutures, it is important to cut the sutures close to the knots and to ensure that exposed suture tails will not come into contact with the leaflet tissue.The most likely cause is use error/procedural factors.Calcific degeneration is a common cause of bioprosthetic heart valve failures.Many factors contribute to the onset and propagation of calcification.These include patient factors (age, disease state, pharmacological intervention, etc.), mechanical stress related to the valve's hemodynamic performance, and glutaraldehyde fixation of tissue.Of these, the fixation process is a relatively minor contributor to calcification for edwards' tissue valves due to anti-calcification treatments during manufacturing.Though numerous studies have been conducted on preventive calcification strategies in bioprosthetic heart valves, the causes of calcification are not fully understood and there are still no mechanisms or medical therapies which fully prevent bioprostheses from calcifying.Calcification is most commonly related to patient factors and is not usually an indication of a device malfunction.A definitive root cause for the calcification cannot be conclusively determined; however, patient factors such as hypercholesterolemia and coronary artery disease likely caused or contributed.

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.

• 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: 17569114
• MDR Text Key: 321401897
• Report Number: 2015691-2023-15310
• 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,Followup
• Report Date: 10/25/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2023
• Supplement Dates Manufacturer Received: 08/24/2023; 09/18/2023; 10/11/2023
• Supplement Dates FDA Received: 09/20/2023; 10/11/2023; 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2021
• 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): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 121 KG