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

Model Number	20000GSA
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	10/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event is captured by edwards lifesciences under complaint #: (b)(4).The manufacturer's investigation is ongoing and a follow-up report will be submitted when the investigation is complete.
Event or Problem Description
Edwards received notification of a pascal in mitral position where during aspiration of the guide sheath just after insertion into la and removal of dilator with wire, st depression was noted on the patients ecg, noting a possible air embolus.Fio2@100% was administered and st changes resolved in approximately 2 minutes.No further patient complication was noted due to this event.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, g3, g6, h2, h6 and h11.The complaint for inadequate aspiration, air remaining in device during insertion was unable to be confirmed as no air was visualized during procedure, no imaging was returned, and no product was returned for evaluation.A dhr review of the lot in question revealed no non-nonconformances related to the event.Follow-up communications with the clinical specialist revealed no identifiable use errors or potential defects with the device.Potential root causes for the presence of air may include: - omission of a flushing/de-airing step.- improper stopcock/syringe technique.- air from an alternative non-pascal device, fluid line, or procedural step.However, a true root case is unable to be determined.

• 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: 20694903
• Report Number: 2015691-2024-08653
• Device Sequence Number: 6555580
• Product Code: NKM
• UDI-Device Identifier: 00690103216967
• UDI-Public: (01)00690103216967(17)250304(11)240304
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P220003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/19/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2025
• Device Model Number: 20000GSA
• Device Lot Number: 65606952
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2024
• 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 Sex: Unknown