MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, LLC CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS; REPLACEMENT HEART VALVE

Model Number	6900P
Medical Device Problem Codes	Calcified (1077); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Dyspnea (1816); Insufficient Information (4580)
Date of Event	07/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: 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
It was learned through implant patient registry that a patient with a 27mm 6900p mitral valve was explanted after an implant duration of 8 years, 6 months due to unknown reasons.The explanted valve was replaced with a 25mm 11400m mitris resilia mitral 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.
Event or Problem Description
It was learned through implant patient registry and investigation that a patient with a 27mm 6900p mitral valve was explanted after an implant duration of eight (8) years, five (5) months due to thickened/restrticted motion leaflets with calcification.Patient presented with shortness of breath and fatigue.The explanted valve was replaced with a 25mm 11400m mitris resilia mitral valve.Patient was stable and was discharged on pod# 9.Per pathology, leaflets noted to be stiffened yet mobile, with multiple calcifications.This is a 70-year-old patient.
Additional Manufacturer Narrative
H11: 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.
Additional Manufacturer Narrative
H11 additional manufacturer narrative: updated sections :g3, g6, h2, h6(type of investigation) corrected sections: h6 ( component code, investigation findings, investigation conclusions) svd is a logical and expected consequence of the chemical, mechanical, and immunological processes associated with bhv implantation.The common endpoint of all these factors is calcification and degradation.Svd is an acquired condition, intrinsic to bioprosthetic valves, characterized by deterioration of the leaflets or supporting structures, leading to thickening, calcification, tearing, or disruption of the prosthetic valve materials.These changes result in valvular dysfunction manifesting as stenosis and/or regurgitation with a consequent drop in hemodynamic efficacy of the valve.Despite the advancements in the heart valve industry, svd commonly begins 7- 8 years after implantation, with a considerably increased rate in patients with pertinent comorbidities and/or an implant duration of greater than 10 years.Prior investigations and extensive literature review have shown that svd is predominantly related to patient factors and implant duration rather than to manufacturing issues.Events related to device design, manufacturing, or use error tend to manifest at an earlier implant duration.Calcification and thickened/restricted leaflet motion were confirmed.X-ray demonstrated wireform intact and heavy calcification was observed on all three leaflets.Moderate host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 11mm on leaflet 3 on the outflow aspect and minimal host tissue overgrowth encroached on the tissue and into the orifice at the greatest distance of approximately 2mm on leaflet 3 on the inflow aspect.Host tissue on the stent circumference was heavy at both the inflow and outflow aspects.Host tissue fused leaflets 2 and 3 by approximately 4mm at commissure 3 on the outflow aspect.Calcification and host tissue overgrowth restricted leaflet mobility and led to stenosis.The most likely root cause is patient factors, including an implant duration of 7 or more years.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.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: CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES, LLC; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES, LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; mle fl2 - office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 20047664
• Report Number: 2015691-2024-06372
• Device Sequence Number: 7933995
• Product Code: DYE
• UDI-Device Identifier: 00690103152647
• UDI-Public: (01)00690103152647(17)190615
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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,Followup
• Report Date (Section B): 11/10/2024

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 Expiration Date: 06/15/2019
• Device Model Number: 6900P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/08/2024
• Supplement Date Received by Manufacturer: 09/25/2024; 11/07/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 10/13/2024; 11/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2015
• 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: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Unknown