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 03/28/2024

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 two devices were implanted.During implantation of the second device, the team started to observe a drop in systemic pressure and heart rate increased to 140-150.After implantation and removal of the guide sheath a tamponade was observed.It was resolved with administering protamine and retracting blood from the pericardial sack percutaneously.No further complication was reported.The patient left the or breathing on his own.The grade of regurgitation before the procedure was 4+ and after the procedure 2.One of the operators thinks that probably during placement of the wire before our gs was introduced, the laa was punctured, but the other opinion from the echo physician is that maneuvering with our device might have damaged the right atrium vault (wall).There was no communication from the implanting team that there were issues with navigating/positioning/usability issues of an edwards device.Challenges were coming from anatomy, making it not possible to catch the flail entirely as it was prolapsing to the left atrium.That is why the operators decided to place the second device medially to the first one to stabilize the leaflets, not laterally (which was the initial idea).

Manufacturer Narrative

The following sections were updated/corrected/added: b4, d4, g3, g6, h2, h6 and h11.The complaint for difficult/unable to insert device into transseptal puncture location was confirmed with other empirical evidence as confirmed by the edwards clinical specialist present at the case.No manufacturing non-conformities were identified from the imaging evaluation.Available information suggests that a combination of patient and procedural factors may have contributed to the reported event.Procedural factors include a potential laa puncture or excess device maneuver near the right atrium wall may have contributed to the patient drop in systemic pressure and cardiac tamponade.Potential patient related factors were anatomical challenges with the leaflet prolapsing into the left atrium making it difficult to catch the flail entirely.

• 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: 19160168
• MDR Text Key: 340791261
• Report Number: 2015691-2024-03068
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)250213
• 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: 05/24/2024

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: 03/28/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 05/24/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/14/2024
• 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: 84 YR
• Patient Sex: Male