MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS INTUITY ELITE VALVE SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 8300AB

Device Problems Perivalvular Leak (1457); Insufficient Information (3190); Activation Failure (3270)

Patient Problems Hemolytic Anemia (2279); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 05/12/2023

Event Type  Injury  

Manufacturer Narrative

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 implant patient registry received information a 25mm 8300ab aortic valve implanted four (4) years, five (5) months, was explanted due to unknown reasons.The explanted device was replaced with a 27mm 3300tfx aortic valve.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional "customer complaint".The information reported may or may not be related to the edwards device.

Manufacturer Narrative

H10: additional manufacturer narrative: lot history review: lot history review was performed per (b)(4) and no similar complaints were found for the lot/wo.The complaints found during the lot history review are not related to the investigation of this complaint because the mechanism of failure is different.Engineering evaluation summary: the complaint was confirmed through medical records.Ifu/labeling are adequate.Rmw is adequate.There is no evidence to suggest an edwards/supplier manufacturing defect.A pra is not required because it does not meet the requirements at this time, per (b)(4) capa/scar is not required.Root cause analysis: the subject device was not returned for evaluation as it was discarded by the hospital and no pictures of the device were provided for evaluation.A dhr review was performed, and no relevant non-conformances were identified.Based on the limited information available, the complaint was confirmed, and the most likely cause is procedural factors, including that in the initial procedure the valve was not fully deployed and there was an area of non-apposition to the ventricular wall and therefore the source of the pvl.An edwards defect has not been confirmed.All pertinent information available to edwards lifesciences has been submitted.

Event Description

It was learned through edwards implant patient registry and medical record that a 25mm 8300ab aortic valve implanted four (4) years, five (5) months, was explanted due to under deployment of valve skirt causing paravalvular leak.The patient presented worsening hemolytic anemia, nyha 11.The explanted device was replaced with a 27mm 3300tfx aortic valve.Per medical record: the patient underwent redo avr, at time of surgery it was noted the subvalvular skirt of the intuity had not been fully deployed and there was an area of non-apposition to the ventricular wall and therefore the source of the pvl.The post cpb tee demonstrated an excellent valvular replacement, no pvl, no stenosis and no new wall abnormalities.

Manufacturer Narrative

H11: corrective data: in the supplemental medwatch# 35018, section h6: 114 - operational problem identified was selected under the investigation findings.However, the section has been corrected and updated to 4248 - usage problem identified based on the additional information obtained from medical record.Engineering evaluation summary has been updated as follows: engineering evaluation summary: the subject device was not returned for evaluation as it was discarded by the hospital and no pictures of the device were provided for evaluation.An operative report was, however, provided for review, confirming the reported partial expansion of the valve frame and describing that further annular debridement was performed prior to implanting the replacement valve.A dhr review was performed, and no relevant non-conformances were identified, and lot history review found no similar incidents.Per technical summary (b)(4), asymmetric frame expansion can occur due to improper seating."asymmetric frame expansion is not considered a failure mode.The shape of the expanded frame is determined by the balloon inflation pressure and by the shape and mechanical characteristics of the valve annulus." based on the limited information available, the complaint was confirmed and likely caused by operational context/procedural factors, including not fully deploying the valve frame at the time of initial implant and potential patient factors of annular calcification.An edwards defect has not been confirmed.All pertinent information available to edwards lifesciences has been submitted.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 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: 17260898
• MDR Text Key: 318446576
• Report Number: 2015691-2023-14355
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2022
• Device Model Number: 8300AB
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2018
• 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: 64 YR
• Patient Sex: Male