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

Model Number	20000ISA
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Additional 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.Device evaluated by mfr: not returned.
Event or Problem Description
Edwards received notification for a pascal in mitral position where air bubbles were introduced into atrium from steerable catheter when first advancing the implant handle.Despite a field trainer double flushing the steerable catheter there were potential air bubbles introduced into the la when the physician first advanced the implant catheter.P10 was prepped by the clinical trainer and the steerable catheter was flushed with 2 full syringes of heparinized saline.Air bubbles were introduced into the la when the implant handle was advanced by the physician for the first time.Dr.Latib was concerned, but there was no harm to the patient and no adverse events.The volume of air ejected from the steerable catheter was greater than what is typically seen during a pascal procedure.Mr severity at baseline was severe 4+ and mr severity post op was severe 4+.
Additional Manufacturer Narrative
Following sections were updated/added/corrected: b4, d4, g3, g6, h2, h4, h6 and h10.The complaint for air bubbles introduced during procedure and/or observed on imaging was confirmed with other empirical evidence via report of the event by an edwards clinical specialist.The complaint was confirmed, however a dhr review of the lot in question revealed no related non-conformances.No imaging or product was returned, so device defects could not be confirmed.Representative units were used for additional testing to evaluate potential mechanisms for air to escape from the is (implant system).The results of the testing showed that in certain scenarios, air introduced into the sc (steerable catheter) can remain seated into the shaft before being pushed out by advancing the ic (implant catheter).Potential root causes for how air enters the sc may include: - improper de-airing technique that leaves air in the sc or ic shafts.- leaks in the system that draw in air prior to device insertion into the patient.- air remaining in pressure monitoring lines that gets pushed into the implant.System upon connection to the sc handle flushport.However, a true root cause 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: 16464194
• Report Number: 2015691-2023-11185
• Device Sequence Number: 12374402
• Product Code: NKM
• UDI-Device Identifier: 00690103216943
• UDI-Public: (01)00690103216943(17)231104
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P220003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 04/13/2023

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 Expiration Date: 11/04/2023
• Device Model Number: 20000ISA
• Device Catalogue Number: 20000ISA
• Device Lot Number: 10248288
• 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: 02/13/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2022
• 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
• Patient Sex: Unknown