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

Model Number 20000GS

Device Problem Air/Gas in Device (4062)

Patient Problem Air Embolism (1697)

Event Date 03/27/2024

Event Type  Injury  

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Event Description

Edwards received notification of a pascal precision procedure in mitral position where during procedure, an air embolism occurred.No anomalies were detected during the guide sheath (gs) preparation.The gs was delivered to interventional cardiologist (ic) with a three-way-stopcock attached to dilator.The gs was advanced until the wire was partway through the introducer.At this point, the three-way-stopcock was removed, and gs was advanced until it entered the left atrium (la) by approximately 2cm.The implant was inserted within the loader through the proximal end of the gs, while flushing into the proximal end of the gs handle with a syringe.Steerable catheter (sc) was advanced, crossing the hemostatic valves.The loader was pulled back and peeled away.During aspiration, some air bubbles were visible in echocardiography.An aspiration of 45cc was performed, revealing an unusual quantity of air aspirated.Approximately half of the syringe was full of air.Changes were observed in the electrocardiogram (ecg), st elevation and hypotension occurred.Adrenaline and volume were given to stabilize the hemodynamic instability.Air bubbles were observed to be in the la and aortic root.The gs aspiration was repeated with a new syringe five minutes later, and no air bubbles were visible.Finally, the gs was flushed with 30cc of saline solution.Adrenaline and volume were administered to normalize ecg.The decision was then made to replace the gs.No further anomalies or serious adverse events occurred during procedure.The patient remained stable throughout the entire procedure.Two ace devices were implanted central-medial.Starting mitral regurgitation (mr) grade was functional 4+ type iiib, and final mr grade was 1+ with a gradient of 2mmhg.Patient was recovered from st elevation and was doing well after the procedure.

• Brand Name: EDWARDS PASCAL PRECISION
• Type of Device: 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: 19159829
• MDR Text Key: 340794715
• Report Number: 2015691-2024-03067
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213331
• UDI-Public: (01)00690103213331(17)241122(11)231123
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P220003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2024

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
• Device Operator: Health Professional
• Device Model Number: 20000GS
• Device Lot Number: 65361942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male