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

Model Number 20000ISM

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Dyspnea (1816); Rupture (2208); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 02/09/2024

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.This mdr is linked to the same case and patient on the other two mdrs with mfr report numbers: 2015691-2024-01966 and 2015691-2024-02232 under complaint numbers (b)(4).

Event Description

Edwards received notification of a pascal precision procedure in mitral position where three pascal precision ace devices were implanted.The mitral regurgitation (mr) was 4+ (massive) before the indexed procedure and 2+ (moderate) after three devices.On post-op day 2, the mr was again at 4+.The patient sought acute help for dyspnea and the echo showed leaflet tearing and recurrent mr.Patient mr etiology is barlows disease.The patient underwent corrective surgery, and the findings were a chord rupture.A video was taken during the surgery which shows the chordae rupture at the lateral commissure.The pascal ace devices were removed, and the patient received a bioprothesis.As per medical opinion the event was not caused by the device.No chords were grasped during the index procedure or other procedural complications.Physicians do not think that pascal devices caused the rupture.

Manufacturer Narrative

The complaint for reduced therapeutic efficacy over time / other was confirmed with objective evidence.No manufacturing non-conformities were identified from the investigation.There is no allegation of device deficiency.There were no intraprocedural issues noted by the clinical specialist.Available information suggests that patient conditions (patient mr etiology is barlows disease) may have contributed to the reported event.However, a definite root cause is unable to be determined.

• 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: 18961897
• MDR Text Key: 338387035
• Report Number: 2015691-2024-02244
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)241210
• 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: 04/29/2024

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: 02/26/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2023
• 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