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

Model Number	20000ISMA
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	07/14/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
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 notification of a pascal in mitral procedure where an implant was attempted and aborted.A patient injury (death) occurred related to the device and procedural complication.Tsp (transseptal puncture) was attempted 3 times.The wire very easily slipped across the ias (interatrial septum).Tsp was reattempted due to height of the first tsp.Clinical specialist mentioned that the wire slipped across the ias like butter yet they did not believe a perforation was created during that procedural step as no effusion was seen at that time.1 ace was placed medial a2p2.The second device was inserted, and upon exiting the guide and closing, it was noted on fluoro that the implant appeared to have tension.Ic was exiting gs (guide sheath) and closing implant without echo guidance and was looking only on fluoro.While on fluoro, ic closed the device and started to flex down, and when echo was visualized again, ec (echocardiographer) informed team that the implant was outside of the pericardium and cardiac tamponade was noted.The team began cpr, and ic proceeded to perform a pericardial tap with copious amounts of very thin blood.Surgical team took over at which point the device was removed.The patient received 8-10 units of blood or more.Ic admitted fault and should have waited for imaging prior to maneuvering the implant.Also of note, patient xarelto had not been held potentially leading to worsening bleeding upon perforation of atrium.The patient ultimately died as the bleeding was significant and unable to be controlled.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, d4, g3, g6, h2, h4, h6 and h11.Additional h6 type of investigation codes to include analysis of images and labeling review.The complaint for inability or difficulty to insert device into transseptal puncture location was confirmed.Per the imaging evaluation performed, there is confirmation of severe hemodynamic disturbance secondary to pericardial effusion that progressed to cardiac tamponade and into mechanical and electrical asystole.There is lack of imaging for the second pascal device described in the allegation.There was no allegation of product malfunction reported.Available information suggests that procedural context (second device inserted, closed implant after exiting the guide, it was noted on fluoro that the implant appeared to have tension.Ic closed implant without echo guidance and was looking only on fluoro) likely contributed to the adverse event.Subsequently, while on fluoro, ic closed the device and started to flex down, and when echo was visualized again, ec informed team that the implant was outside of the pericardium and cardiac tamponade was noted.The device history record review was completed, and this device passed all manufacturing and sterilization inspections.No nonconformances related to the complaint event were identified.Since no edwards defect was identified, corrective or preventative actions are not 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: 22576793
• Report Number: 2015691-2025-05978
• Device Sequence Number: 21242030
• Product Code: NKM
• UDI-Device Identifier: 00690103216950
• UDI-Public: (01)00690103216950(17)260331
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/05/2025

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: 03/31/2026
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2025
• 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; Death
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 137 KG