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

Model Number	20000ISM
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the report received from czech republic, edwards received notification of a pascal precision ace procedure in tricuspid position.On post operative day (pod) 320, a single leaflet device attachment (slda) was identified.The patient, who initially presented with functional torrential tricuspid regurgitation (tr), underwent transcatheter edge to edge repair (teer) with two pascal precision ace devices in the anteroseptal (as) position on 24th april 2025.The procedure resulted in residual mild tr.On pod 320 a slda affecting the second implanted ace was detected.The patient developed recurrent severe tr with anatomical features including annular dilatation and chordal rupture.The chordal rupture had not been observed during the index procedure nor during early follow up assessments.The fcs suspects the device may have grasped chordae instead of leaflet tissue, ultimately leading to late detachment due to the fragility of this soft tissue; however, this has not been confirmed.At the time of this investigation, there is an intention to treat the patient in the future, although no reintervention has been scheduled at this moment.
Additional Manufacturer Narrative
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 in the us, addressing degenerative mitral regurgitation.But, it is approved for both tricuspid and mitral spaces in the region where the procedure was performed.Therefore, deployment in the tricuspid position will not be considered off-label in this case.

• 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: 24740734
• Report Number: 2015691-2026-13687
• Device Sequence Number: 8731023
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)250904(11)240904
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P220003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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: 09/04/2025
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2024
• 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: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Unknown