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

Model Number 20000ISM

Device Problem Migration (4003)

Patient Problems Foreign Body Embolism (4439); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 06/05/2023

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.It should be noted, the device was implanted in the tricuspid position.At this time, the pascal precision transcatheter valve repair system is only indicated for the native mitral valve in the us, addressing degenerative mitral regurgitation.But, it is approved for both tricuspid and mitral spaces in the region where the procedure was performed.Therefore, deployment in the tricuspid position will not be considered off-label in this case.Not returned.

Event Description

Edwards received notification of a pascal precision ace procedure in tricuspid position where a device embolization occurred.The first device was placed a/s in the commissure because the septal sail a/s central was too restrictive.The second device was planned to have only been placed parallel to the first a/s, but since the sail material was not sufficient, the strategy was changed, and it was tried to place the second device p/s.Visibility in the rv inflow outflow with x plane was poor, so it was resorted to transgastric, but a few times still, one of the two sails was not gripped well.After three hours, the doctor wanted to finish and release even though the clinical specialist advised the posterior sail to optimize.After the actuation wire was pulled out, the posterior sail released immediately.In the tg short axis, it was clearly visible that only the tip of the posterior sail was gripped.When trying to stabilize the released device with a third ace the device released completely.The physician kept touching it with the third device and the third device was bailed out.The detached device could not be recovered with a snare.After contrast was given, it looked like the device was lying on the floor of the atrium, but was not visible on echo.The clinical specialist spoke with the doctor and the patient was doing good and was stable in a normal ward.The embolized device lies firmly in the proximal part of the coronary sinus with a moderate ti.There is no further intervention planned.

Manufacturer Narrative

The complaint for implant detaches from both leaflets into vasculature (intra-procedure) was confirmed with other empirical evidence based on accounts by the edwards clinical specialist present during the case.No manufacturing non-conformities were alleged in the reported event or found during the evaluation.Available information suggests that procedural use-related factors during the procedure, including the device not being used in accordance with recommendations in the ifu and training manuals, most likely contributed to the reported 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: 17219162
• MDR Text Key: 318036322
• Report Number: 2015691-2023-14218
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)240510
• 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: 07/26/2023

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 Expiration Date: 05/10/2024
• Device Model Number: 20000ISM
• Device Catalogue Number: 20000ISMA
• Device Lot Number: 10809716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 06/28/2023
• Supplement Dates Manufacturer Received: 07/24/2023
• Supplement Dates FDA Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male