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

Model Number 20000ISM

Device Problem Difficult to Insert (1316)

Patient Problems Pericardial Effusion (3271); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/09/2024

Event Type  Injury  

Event Description

Edwards received notification of a pascal precision ace procedure in mitral position.During procedure the patient suffered a pericardial effusion.The patient needed treatment of a severe mitral regurgitation (mr).The heart and especially the right atrium were massively enlarged, which made puncture of the septum difficult.This was finally successful, and a stiff wire was inserted into the left atrium.In retrospect, physician said that he was not sure whether the wire had temporarily pierced the myocardium.However, there were no hemodynamic signs of injury, so the procedure was continued.The first ace was implanted satisfactorily but was not sufficient to adequately treat the mr.When the second device was steered down, there was brief contact with the atrial wall between the superior pulmonary vein and the atrial appendage.The device stalled briefly, and contact was made.Afterwards, the physician reported that the contact was probably not sufficient to damage the heart wall.The second device was implanted satisfactorily after a small correction.A little later, the anesthesiologist pointed out that the frequency had risen to 140-150bpm and that the pressure had dropped at the same time (70/50).A pericardial effusion was visible in the echo.The administration of catecholamines did not lead to any improvement.The pascal was released, and the pericardial puncture was initiated.A total of 450 ml of blood was drawn and the patient's parameters improved.The patient was stabilized and transferred to the icu.A week after, patient was noted as to be feeling better and recovering.The result of the procedure was stable and still good.Physician's primary suspicion lies in the accidental injury to the heart with the wire.As reported, in case that the wire was the cause for the tamponade it occurred probably in the left atrium.

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).H6 clinical code: hemodynamic instability.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 difficult/unable to insert device into transseptal puncture location was confirmed with other empirical evidence.No manufacturing non-conformities were identified from the investigation.As there were no images provided for this adverse event, an imaging evaluation could not be performed.There was no allegation of product malfunction reported.Available information suggests that patient conditions (the heart and especially the right atrium were massively enlarged, which made puncture of the septum difficult) and procedural use (in retrospect, physician said that he was not sure whether the wire had temporarily pierced the myocardium.Physician's primary suspicion lies in the accidental injury to the heart with the wire) likely contributed to the adverse 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: 18837655
• MDR Text Key: 336901012
• Report Number: 2015691-2024-01586
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)250103
• 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: 03/28/2024

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
• Device Lot Number: 11596733
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2024
• 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 Age: 44 YR
• Patient Sex: Female