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

Model Number	20000ISMA
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	04/03/2025
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.
Event or Problem Description
Edwards received a report of a pascal procedure in mitral position where when implanting a 3rd pascal, the implant release was difficult when detaching from the attachment fingers.All troubleshooting techniques specified in the procedural manual were attempted without success.The physician then gave the implant system an abrupt, quick, and firm yank while mounted in the srs at which point the implant released.The tug on the device resulted in posterior leaflet being pulled out of the device's grasp.It was noted the 3rd implant was stable and not mobilized, only rocking with the cardiac motion.The patient's mr was reduced from severe to moderate/severe only after implantation of the 3rd device.Device was stable and patient was discharged without further incident the following morning.There were noted anatomical challenges.The atrium was noted to be a huge atrium measuring 9x9 mm with a tsp height of 5x5 mm resulting in very difficult imaging during the case.There was no device issue perceived from the site, but the cs mentioned the other colleague determined the reason for difficulty removing the device was that they lost too much height to reach target location, resulting in extra tension in the system once the actuation wire was retracted.
Additional Manufacturer Narrative
The complaint for implant dislodged from a single leaflet, single leaflet device attachment (slda) intra-procedure was confirmed with empirical evidence.As the device was confirmed to be released from the wire and the fingers were open, it is believed that there was additional force placed on the system, either from prior procedural steps, through patient anatomy, or interaction with the 2 previously implanted devices, that caused the inability for the fingers to release.The disengagement of the device through a forceful pull of the implant system was the likely cause of the slda as described by the edwards clinical specialist.A dhr review was performed for the device and no manufacturing non-conformances related to this complaint event could be identified, and no labeling, training, or ifu deficiencies were found.Therefore, no preventative action or capa was required.

• 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: 21926352
• Report Number: 2015691-2025-03360
• Device Sequence Number: 20995428
• Product Code: NKM
• UDI-Device Identifier: 00690103216950
• UDI-Public: (01)00690103216950(17)250828
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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: 08/28/2025
• Device Model Number: 20000ISMA
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Male