MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS PASCAL PRECISION; MITRAL VALVE REPAIR DEVICES

Model Number	20000ISM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cusp Tear (2656); Tricuspid Valve Insufficiency/ Regurgitation (4453)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B2: other serious- even though there was no reintervention, there is a potential for reintervention in this case.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.It should be noted, the device was implanted in the tricuspid position.At this time, the pascal precision transcatheter valve repair system is only indicated for the native mitral valve, addressing degenerative mitral regurgitation.Therefore, deployment in the tricuspid position is considered off-label.
Event or Problem Description
Edwards received a report of a pascal procedure in tricuspid position where there was worsening tr.30 day tte done on pod 44 shows tr as moderate, and 6 month tte done on pod 177 severe tr likely due to a leaflet perforation suspected around the 30 day timepoint.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, g3, g6, h2, h6 and h11.Additional information was received that on pod 217 the patient underwent reintervention to explant the pascal device and implant a 44mm evoque.The pascal was in a central anterior/septal location.It was not stable and the physician thought it could easily come off the anterior leaflet.Day of procedure, the physician decided to lacerate the pascal device off the anterior leaflet, before the patient was treated with evoque.While attempting to remove the pascal device, the patient developed a pericardial effusion 2/2 ivc/ra tear.It is believed that the ra injury happened when the catheters were being pulled back after the laceration.The patient developed cardiac tamponade/pea arrest requiring a sternotomy and resuscitation with blood products.The ivc/ra repaired, and the evoque was successfully completed without bypass.The patient was admitted to the icu for post-op management and was doing better after deployment.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, d4, g3, g6, h2, h4, h6 and h11.Additional type of investigation codes that were unable to be added in h6: analysis of images.The complaint for implant damages leaflets over time was not confirmed, and no alleged device nonconformities were confirmed via the imaging evaluation.After an internal review of multiple core lab reports of sequential echocardiograms, and after reviewing the imaging of the pascal index procedure, the allegation of progression of tr and the allegation of leaflet perforation was unable to be confirmed.In the most recent 6 month follow up tte, core lab read the residual tr as of moderate severity and reported no evidence of leaflet perforation.

• Brand Name: EDWARDS PASCAL PRECISION
• Common Device Name: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: cassandra cook ; 1 edwards way; irvine, CA 92614 ; 5743778277
• MDR Report Key: 21926403
• Report Number: 2015691-2025-03361
• Device Sequence Number: 15724825
• Product Code: NKM
• UDI-Device Identifier: 00690103216950
• UDI-Public: (01)00690103216950(17)250422
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P220003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2025

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: 04/22/2025
• Device Model Number: 20000ISM
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 05/20/2025; 07/02/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 06/12/2025; 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2024
• 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: Other
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 63 KG