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

Model Number	8300AB
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Codes	Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446)
Date of Event	07/15/2024
Type of Reportable Event	Serious Injury
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 or Problem Description
Through implant patient registry and medical records, it was learned a 23mm 8300ab aortic valve, was explanted after an implant duration of four (4) months due to a paravalvular leak resulting in regurgitation.The patient presented to the hospital with heart failure and progressive dyspnea.The explanted device was replaced with a 27mm 11500a valve.Per medical records, patient presented to osh 06/2024 in the setting of decompensated heart failure.A tee at that time revealed pvl on the bioprosthetic valve placed 03/2024.The patient was discharged home and referred to another facility for surgical evaluation.Repeat imaging revealed severe pvl and the 23mm 8300ab to be unstable.The patient underwent a re-do avr with a 27mm 11500a.Intraoperatively, a large gap was noted between the native aortic annulus and bioprosthetic valve which was determined to be the cause of a severe pvl as well as an incomplete debridement with extensive calcification of the aortic annulus.The 23mm 11500a valve was explanted, the annulus was meticulously debrided and a 27mm 11500a was seated.A final post-bypass tee revealed a mean gradient of 10mmhg across the aortic prosthesis with no pvl identified.The patient tolerated the procedure well and was transferred to cticu in stable condition.Per pathology reports, there is an intact bioprosthetic av measuring 2.7 x 2.7 x 2.2cm as well as a 3 x 1.7 x 0.6cm aggregate comprised of disrupted tan-gray glistening, partially calcified tissue fragments.No discrete lesions or masses are appreciated grossly.
Additional Manufacturer Narrative
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.Engineering evaluation summary: per technical summary (b)(4), rev a, regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bioprosthetic sewing ring and the annulus.Pvl can occur in the mitral and aortic position for similar reasons.In the early postoperative period, the highest incidence of pvl has been seen in patients developing infective endocarditis, which is most likely attributed to inadequate peri-operative antibiotic prophylaxis or nosocomial infection.Annular calcification is also a risk factor for the development of peri-operative pvl as the bio prosthesis may not seat properly after debridement.Technique related factors, such as incorrect valve sizing, have been shown to contribute to the development of pvl.Anatomical factors may create difficulty seating the bioprosthetic valve resulting in pvl.The anatomy of the annulus may induce mechanical stresses along the rigid bioprosthetic ring which can influence long-term valve performance and durability.A diseased or rigid annulus can potentially increase the mechanical stress on the prosthetic valve, leading to pvl.Per (b)(4), rev p, an engineering evaluation is not required because there is no allegation of a malfunction which could be related to a manufacturing non-conformance and/or one was not suspected or confirmed through investigation; no labeling non-conformance/deficiency; no use-related issue with a hazardous situation; no device-related infection; and no evidence of a product failure with regard to design, reliability, or use error.Additionally, relevant technical summary (b)(4), rev a, exists for this issue.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.Per (b)(4), rev p, and (b)(4), rev o, a capa/scar/pra is not required, as there are no confirmed product or labeling non-conformances, and no other triggers are met.A definitive root cause cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.All pertinent information available to edwards lifesciences has been submitted.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Common Device Name: 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: 20013153
• Report Number: 2015691-2024-06211
• Device Sequence Number: 15261570
• Product Code: LWR
• UDI-Device Identifier: 00690103194494
• UDI-Public: (01)00690103194494(17)270604
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P150036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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
• Operator of Device: Health Professional
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male