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

Model Number 20000ISM

Device Problem Difficult to Insert (1316)

Patient Problem Cardiac Perforation (2513)

Event Date 01/09/2024

Event Type  Injury  

Event Description

Edwards received notification of a pascal ace precision procedure in mitral position where the patient received a mitraclip six years ago and a triclip in the middle of last year (both from abbott).The insufficiencies on both the mitral side and the tricuspid side were not resolved, therefore the patient was being treated with a pascal (mitral).The device was implanted satisfactorily, and the system was retracted across the septum.After a short delay, the saturation of the patient, who was under sedation, fell abruptly to below 80.An exclusion coronary angiography was performed, which revealed nothing.The echo showed that the iasd from the previous 6-year-old procedure was still open.The two holes in the septum, in combination with the residual torrential tr which was not addressed during this procedure, contributed to the right-to-left shunting and were considered to be the cause of the drop in saturation.The hole in the septum for this procedure was closed with an 8 mm asd closure device, whereupon the patient's vital signs improved again.The patient survived the procedure without any further consequences.As per response follow up the physician accidentally hit the old hole in the septum at the first moment.However, this seemed to be unsuitable in terms of height, so an optimal new puncture site was sought and found.There were no problems when passing through the septum.The implantation of the pascal went without complications and was inconspicuous until the guide was withdrawn at the end of the procedure.

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.H3 other text : device remains implanted.

Manufacturer Narrative

The complaint for difficult/unable to insert device into transseptal puncture location was confirmed with other empirical evidence.No manufacturing non-conformities were able to be identified from the imaging evaluation, as it was not received.Also, 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.Available information suggests that patient conditions (iasd from other mitral valve repair procedure) and procedural factors (guide sheath manipulations, and procedural time) may have contributed to the reported event.

• 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: 18630365
• MDR Text Key: 334427916
• Report Number: 2015691-2024-00740
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)240904
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 03/11/2024

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?: No
• Device Model Number: 20000ISM
• Device Lot Number: 11203715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 02/02/2024
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2023
• 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 Sex: Female