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

Model Number 20000ISM

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cusp Tear (2656)

Event Date 01/03/2024

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 ace procedure in mitral position where one day after the procedure, a perforation was observed in the anterior mitral leaflet (aml) in between the pascal device and the annulus, and patient underwent surgical valve replacement.There were no particular incidents during the index procedure.Starting mitral regurgitation (mr) grade was 3 with a mitral valve (mv) gradient of 2mmhg, and post-procedure mr grade was 1 with a mv gradient of 4mmhg.The mr and the patient's condition deteriorated.Subsequently, the decision was made to proceed with surgical treatment for mitral valve replacement.The patient's condition has stabilized after the surgery.According to the physician, follow-up imaging revealed that the most likely cause was inclusion of a chordae when capturing the aml.The doctor did not suspect a malfunction of the device.

Manufacturer Narrative

The presence of this leaflet damaged while capturing as described in the complaint event was confirmed with other empirical evidence through testimony of the edwards on-site clinical specialist.Based on review of investigation findings, potential contributing factors are procedural conditions (capturing a chord in anterior mitral leaflet, targeted trajectory, and incorrect maneuvers and orientation).Furthermore, the reported leaflet damaged while capturing event does not allege a malfunction that could be related to an edwards manufacturing deficiency, and one was not confirmed as no imaging evaluation was returned.

Manufacturer Narrative

The following sections were updated/corrected/added: b4, g3, g6, h2, h6 and h11.The complaint for leaflet damaged while capturing was confirmed with objective evidence.The presence of this leaflet damaged while capturing as described in the complaint event was confirmed with objective evidence through imaging evaluation.Based on review of investigation findings, potential contributing factors to leaflet damaged while capturing are procedural conditions (the inaccurate view planes used for grasping, aml leaflet tip curling, and 90-degree angle between the aml-to-anterior paddle capturing a chord in anterior mitral leaflet, change in implant orientation with partial tissue bridge).This reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency, and one was not confirmed through the returned imaging evaluation.In addition, a dhr review was completed and no nonconformances related to the complaint event were identified.

• 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: 19093137
• MDR Text Key: 339965488
• Report Number: 2015691-2024-02791
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)240628
• 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: 05/14/2024

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: 20000ISM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/29/2023
• 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