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

Model Number 20000ISMA

Device Problems Device Damaged by Another Device (2915); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2023

Event Type  Injury  

Event Description

Edwards received notification of a pascal in mitral position where the procedure went smoothly, but after the clasps were lowered and device was completely closed, the ic noticed that the rv lead was more mobile and may have dislodged.Ic consulted with ep md and decided to put in a leadless pacemaker after pascal ace was deployed.The procedure was completed successfully with mr reduction from severe to moderate.

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 : implanted.

Manufacturer Narrative

The following sections were updated/corrected/added: b4, d4, g3, g6, h2, h4, h6 and h10.The complaint for interaction with previously implanted devices was confirmed with other empirical evidence based on the event reported by the edwards clinical specialist on-site during the procedure.No manufacturing non-conformities were identified from imaging evaluation as it was not received.Available information suggests that procedural conditions (standard access to mitral valve, and excessive manipulations of the delivery system) may have contributed to the reported event.

Manufacturer Narrative

The following sections were updated/corrected/added: b4, g3, g6, h2, h6 and h11.H6 impact code was corrected from initial mdr.

• 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: 18437638
• MDR Text Key: 331822435
• Report Number: 2015691-2024-00028
• Device Sequence Number: 1
• Product Code: NKM
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2024

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 Operator: Health Professional
• Device Model Number: 20000ISMA
• Device Lot Number: 11424840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 02/06/2024; 05/15/2024
• Supplement Dates FDA Received: 02/06/2024; 05/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2023
• 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