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

Model Number	6900PTFX
Medical Device Problem Codes	Calcified (1077); Gradient Increase (1270); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446)
Date of Event	09/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: additional narratives.Surgical/percutaneous intervention is indicated or performed, or harm occurred due to the device, or there is a device malfunction that could cause or contribute to a serious injury.This event is considered a serious injury.The device was returned and product evaluation 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.
Event or Problem Description
Edwards received notification from the patient with a 29mm mitral valve underwent a redo procedure after an implant duration of 6 years, 4 months due to severe stenosis.The patient presented with chf and sob.
Additional Manufacturer Narrative
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
Edwards received notification that a 6900ptfx 29mm mitral valve was explanted after an implant duration of 6 years, 4 months due to severe stenosis.The patient presented with chf and sob.Per product evaluation vegetation, calcification, and pannus were confirmed.
Additional Manufacturer Narrative
H10: additional narratives.H3: product evaluation.Customer report of stenosis was confirmed through observed host tissue overgrowth and calcification.X-ray demonstrated wireform intact, moderate calcification on leaflet 1, and heavy calcification on leaflet 3.Host tissue overgrowth on the stent circumference was moderate at the outflow aspect and minimal at the inflow aspect.Moderate to heavy host tissue overgrowth fused leaflets 1 and 2 by approximately 10mm at commissure 2 and leaflets 2 and 3 by approximately 10mm at commissure 3 on the outflow aspect.Subvalvular apparatus was also observed around the valve along with the host tissue overgrowth.What appeared to be organic material was also observed on the surfaces of all three leaflets near the free margins on the inflow aspect.Calcification and host tissue overgrowth restricted leaflet mobility and led to stenosis.Sewing ring cloth was cut in multiple areas around the valve exposed the metal band around leaflets 1 and 3 on the inflow aspect.A definitive root cause cannot be conclusively determined; however, patient factors likely caused or contributed.The device history record (dhr) was not reviewed as the reported event does not allege a malfunction that could be related to a manufacturing deficiency and/or one was not confirmed through investigation.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.Corrected data: "vegetation" was removed in h3.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17998544
• Report Number: 2015691-2023-17033
• Device Sequence Number: 12443881
• Product Code: DYE
• UDI-Device Identifier: 00690103163605
• UDI-Public: (01)00690103163605(17)200917
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 01/10/2024

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: 09/17/2020
• Device Model Number: 6900PTFX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• 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: 09/30/2023
• Supplement Date Received by Manufacturer: 10/17/2023; 01/04/2024
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/06/2023; 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2016
• 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: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female