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

Model Number	2700
Medical Device Problem Codes	Calcified (1077); Degraded (1153); Device Stenosis (4066)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: additional manufacturer narrative: the device was not returned for evaluation, as the device request is ongoing.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 the implant patient registry and investigation that a 27mm 2700 aortic valve was explanted after an implant duration of eight (8) years, eleven months due to calcified degeneration and severe stenosis.The valve was replacement with a 25mm 11500a valve.Per medical records, the patient presented with shortness of breath and underwent redo avr with ascending aorta replacement with 30mm gelweave graft and septal myectomy.Operative findings/tee showed prosthetic aortic valve calcified degenerated which caused severe stenosis.Aorta ascending aneurysm (root and arch intact), hypertrophic septum.The 25mm 11500a valve was implanted with pledgeted non-everting mattress sutures.The patient tolerated the procedure well with no immediate complications and was discharged on pod #6.Per hospital pathology report: gross exam, 3 aortic cusps are markedly calcified and immobile, there is mild pannus present.One of the cusps is torn.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.
Additional Manufacturer Narrative
H3: per product evaluation: report of calcified degeneration and stenosis were confirmed through observed calcification and leaflet tear.X-ray demonstrated wireform intact.Extrinsic calcific deposits were observed on the surfaces of leaflets 1 and 2 on the inflow aspect.Heavy calcification was observed on leaflets 1 and 2, and minimal calcification on leaflet 3.Moderate host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 3mm on leaflet 3 on the inflow aspect and 2mm on leaflet 3 on the outflow aspect.Host tissue on the stent circumference was moderate at both the inflow and outflow aspects.Leaflet 1 had a 4mm tear near commissure 2 and calcification was evident at the tear.Calcification restricted leaflet mobility and led to stenosis.Sewing ring had multiple cuts around the valve.
Additional Manufacturer Narrative
H10: additional manufacturer narrative.Updated sections: d4 (expiration date), g3, g6, h2, h4, h6 (type of investigation, investigation findings, and investigation conclusions).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.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.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.Based on the information available, the most likely root cause is patient factors, including an implant duration of 7 or more years and hyperlipidemia (hld).

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT, HEART-VALVE
• 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; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 20162373
• Report Number: 2015691-2024-06904
• Device Sequence Number: 7291284
• Product Code: DYE
• UDI-Device Identifier: 00690103021622
• UDI-Public: (01)00690103021622(17)181215
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2024

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: 12/15/2018
• Device Model Number: 2700
• 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: 08/14/2024
• Supplement Date Received by Manufacturer: 09/13/2024; 11/15/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 10/07/2024; 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2014
• 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: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 56 YR
• Patient Sex: Male