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

Model Number 11500A27

Device Problem Central Regurgitation (4068)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 03/01/2024

Event Type  Injury  

Event Description

It was learned through the patient support center and medical records that a patient with a 27mm 11500a valve in the aortic position underwent a valve-in-valve procedure after an implant duration of 4 months and 27 days due to moderate to severe aortic insufficiency.The patient presented with decreased exercise tolerance , fatigue, and nyha class iii symptoms.The tavr was performed with a 29mm non-edwards transcatheter valve.The patient was discharged to home on pod#1.The patient's spouse reported that he implant md informed patient that there was a small leak in the corner of the valve but not to worry because it would eventually seal all the way.The patients spouse also reported that it was explained to them that the leak might have occurred because edwards valves are made by humans and that a stitch might have gotten wrong.Per medical records, initially post op echo revealed acceptable valve prosthesis and no pvl, mild leak at he commissures within the right left leaflets of the valve, not enough to warrant re-exploration.The patient initially was doing well post avr with steady increase in activity up to 2 miles per day.Approximately two months post implant the patient experienced fatigue and decreased exercise tolerance.A tee showed normal lv and moderate ai at the right coronary cusp.It is noted the rcc appears tethered.Mri showed moderate to severe ar.It is noted there is no obvious pvl or svd the ar appears to be within the valve , there may be tethering or leaflet fracture.His symptoms worsened over the next month , nyha 3 and bilateral numbness in both feet and he underwent a valve in valve procedure.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Manufacturer Narrative

H11: additional manufacturer narrative: trivial/trace to mild amounts of ar are not unusual post operatively in bioprosthetic valves.This is usually tolerated by the patients.Like mr, if the regurgitation worsens or becomes symptomatic, reoperation may be necessary.Almost all pericardial bioprosthesis have some level of central leak postoperatively, especially when systolic pressure is low and or prior to protamine administration and is usually tolerated by patients.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.Based on the information available, a definitive root cause is unable to be determined.

Manufacturer Narrative

H11: additional manufacturer narrative: updated: b4, g3, g6, h2, h6.Correction: b5, b7.

Event Description

It was learned through the patient support center and medical records that a patient with a 27mm 11500a valve in the aortic position underwent a valve-in-valve procedure after an implant duration of 4 months and 27 days due to moderate to severe aortic insufficiency.The patient presented with decreased exercise tolerance , fatigue, and nyha class iii symptoms.The tavr was performed with a 29mm non-edwards transcatheter valve.The patient was discharged to home on pod#1 the patients spouse reported that he implant md informed patient that there was a small leak in the corner of the valve but not to worry because it would eventually seal all the way.The patients spouse also reported that it was explained to them that the leak might have occurred because edwards valves are made by humans and that a stitch might have gotten wrong.Per medical records, initially post op echo revealed acceptable valve prosthesis and no pvl, mild leak at he commissures within the right left leaflets of the valve, not enough to warrant re-exploration.The patient initially was doing well post avr with steady increase in activity up to 2 miles per day.Approximately two months post implant the patient experienced fatigue and decreased exercise tolerance.A tee showed normal lv and moderate ai at the right coronary cusp.It is noted the rcc appears tethered.Mri showed moderate to severe ar.It is noted there is no obvious pvl or svd the ar appears to be within the valve , there may be tethering or leaflet fracture.His symptoms worsened over the next month , nyha 3 and bilateral numbness in both feet and he underwent a valve in valve procedure.

• Brand Name: EDWARDS 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18987061
• MDR Text Key: 338717636
• Report Number: 2015691-2024-02345
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103195002
• UDI-Public: (01)00690103195002(17)270702(11)230703
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2023
• 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: 70 YR
• Patient Sex: Male