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

Model Number 11500A

Device Problem Calcified (1077)

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

Event Type  Injury  

Manufacturer Narrative

Attempts to retrieve the device and additional information are in process.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 valve model 11500a21 implanted in aortic position was explanted from a 65-year-old patient after an unknown implant duration, however no longer than six (6) years and one (1) month due to calcific degeneration affecting the three leaflets, and mild pannus under the ring.Another bioprosthetic valve was implanted in replacement.Unfortunately, patient passed away few days after redo procedure due to a stroke.The cause of death was not imputed to the edwards device, but to carotid stenosis.As reported, this affection had not been previously identified.

Manufacturer Narrative

H3: evaluation summary: customer report of calcification, pannus and stenosis were confirmed.X-ray demonstrated commissures 1 and 2 were bent outwards and cocr band intact; the vfit cocr alloy band was not expanded.Heavy calcification was observed on leaflets 2 and 3, and minimal calcification on leaflet 1.Extrinsic calcific deposits were observed on the inflow and outflow surfaces of leaflets 2 and 3.Minimal host tissue overgrowth encroached onto the leaflet and into the orifice at the greatest distance of approximately 3mm on leaflet 2 on the inflow aspect.Host tissue on the stent circumference was minimal at the inflow aspect.Calcification restricted leaflet mobility and led to stenosis.Multiple suture holes were observed around the sewing ring.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 valve model 11500a21 implanted in aortic position was explanted from a 65-year-old patient after an implant duration of six (6) years and (28) twenty-eight days due to calcific degeneration affecting the three leaflets, and mild pannus under the ring leading to stenosis (mean gradient of 59mmhg).As reported, patient presented with dyspnea.Another bioprosthetic valve was implanted in replacement.Unfortunately, patient passed away few days after redo procedure due to a stroke.The cause of death was not imputed to the edwards device, but to carotid stenosis.As reported, this affection had not been previously identified.As per medical records, patient had a recurrent epilepsy seizure after surgery and a medical treatment was indicated.An angiography of supra aortic arteries showed a 70 % stenosis (nascet criteria) of the right carotid at the level of the carotid bulb and a 75 % stenosis at the origin of the left subclavian artery.A ct scan on # pod 2, showed a massive right ischemic mca stroke with cerebral edema and mass effect.

• 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 ; one edwards way; mle fl2 office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 19125773
• MDR Text Key: 340448420
• Report Number: 2015691-2024-02913
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194975
• UDI-Public: (01)00690103194975(17)190525
• 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
• Report Date: 05/13/2024

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 Expiration Date: 05/25/2019
• 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: 03/27/2024
• Initial Date FDA Received: 04/17/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2017
• 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): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 78 KG