MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC PASCAL PRECISION SYSTEM ¿ IMPLANT SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number	20000IS
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Pascal device during transcatheter edge to edge mitral valve repair- metal material from catheter detached during second device deployment requiring snare retrieval.Metal material was embolized into internal iliac artery.No obvious patient harm at this time.Mitral valve repair itself was successful.

• Brand Name: PASCAL PRECISION SYSTEM ¿ IMPLANT SYSTEM
• Common Device Name: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 16130450
• Report Number: 16130450
• Device Sequence Number: 3364237
• Product Code: NKM
• UDI-Device Identifier: 00690103216943
• UDI-Public: 00690103216943
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2022
• Report Date (Section F): 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 20000IS
• Device Catalogue Number: 20000ISA
• Device Lot Number: 100041416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/15/2022