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

Model Number	6900PTFX
Medical Device Problem Codes	Calcified (1077); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Dyspnea (1816); Insufficient Information (4580)
Date of Event	03/17/2025
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 27mm 6900ptfx mitral valve was explanted after an implant duration of 8 years, 2 months due to unknown reason.The explanted device was replaced with a 27mm 11400m 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.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated: b4, b5, b7, g3, g6, h2, h6 (health effect - clinical code, device code, type of investigation).H11: corrected data: based on the additional information obtained, this event is considered reportable, and this correction is being submitted.
Event or Problem Description
It was learned through implant patient registry and investigation that a 27mm 6900ptfx mitral valve was explanted after an implant duration of 8 years, 2 months due to calcification, severe mitral regurgitation and leaflet torn.The patient presented with shortness of breath.The explanted device was replaced with a 27mm 11400m mitris resilia mitral valve.The patient was stable post procedure and was discharged on pod#7.Per medical records, pre-operative tee confirmed severe mitral regurgitation and the appearance of torn leaflets.The patient underwent a redo mitral valve replacement.Intraoperatively there was no signs of endocarditis, but few specimens were taken and sent for pathology investigation.The initial mitral valve was explanted and the annules was debrided and a 27mm 11400m mitris resilia mitral valve was implanted successfully.Post operative tee showed normal functioning bio prosthesis mitral valve without evidence of pvl.The patient tolerated the procedure well and was transferred to icu in stable condition, then was discharged on pod#7.Per pathology report, the explanted device tested positive for gram-positive cocci and cutibacterium modestum.There is also background of fibrosis and leaflets were irregular, nodular, with focal calcification consistent with mitral regurgitation.
Additional Manufacturer Narrative
Updated: b4, b5, g3, g6, h2 h11: corrected data.Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.
Event or Problem Description
It was learned through implant patient registry and investigation that a 27mm 6900ptfx mitral valve was explanted after an implant duration of 8 years, 2 months due to cutibacterium modestum endocarditis.The explanted device was replaced with a 27mm 11400m mitris resilia mitral valve.Per pathology report, the explanted device tested positive for gram-positive cocci and cutibacterium modestumi.There is also background of fibrosis and leaflets were irregular, nodular, with focal calcification consistent with mitral regurgitation.
Additional Manufacturer Narrative
H11: additional manufacturer narrative: updated: b4, g3, g6, h2, h6 (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.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.Intermediate/late onset endocarditis (i.E.Greater than 60 days post-implant) occurs due to the implant being seeded from an infection or microbial contamination from elsewhere in the patients body and is not in any way related to the sterilization or packaging process of the device.The microorganism for intermediate/late onset prosthetic device endocarditis may be due to hospital-acquired infections of lower pathogenicity or community-acquired infections.Common sources of endocarditis include dental, surgical, or endoscopic procedures; iv drug abuse; or recurrent endocarditis.There is no evidence to suggest a manufacturing defect caused or contributed to the reported event.Based on the information available, the most likely cause is patient factors.The device history record (dhr) was not reviewed as the reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency 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.H11: corrected data: h6 (component code, type of investigation).

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 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: 22188814
• Report Number: 2015691-2025-04762
• Device Sequence Number: 15600573
• Product Code: DYE
• UDI-Device Identifier: 00690103163599
• UDI-Public: (01)00690103163599(17)200831(11)160901
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: 2025
• 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,Followup
• Report Date (Section B): 07/14/2025

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: 08/31/2020
• Device Model Number: 6900PTFX
• 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: 05/19/2025
• Supplement Date Received by Manufacturer: 06/23/2025; 07/03/2025; 07/08/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 06/26/2025; 07/04/2025; 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2016
• 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; Required Intervention; Life Threatening
• Patient Age: 58 YR
• Patient Sex: Male