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

Model Number 20000ISM

Device Problem Device Damaged by Another Device (2915)

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

Event Date 02/15/2024

Event Type  Injury  

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: 2024-04026-02 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.

Event Description

Edwards received notification of a pascal procedure in tricuspid position where one year and eight months after the procedure the patient developed dyspnea and fatigueless sought help.A late slda was seen on one of the two devices the patient received (posterior-septal detached on the septal side) and a reintervention has been taken place.The strategy was to place one pascal precision ace device next to the slda to stabilize it and also to reduce the tricuspid regurgitation tr).Several attempts were done, eventually the slda-device got stuck in the new pascal retention features on one of the clasps.During maneuvering to attempt to get free from the slda-device, the slda-device detached completely from the posterior leaflet and was stuck to the new pascal retention features/clasp.The doctors pulled back the whole system with the attached slda-device to the abdominal vein to the point of the femoral bifurcation.The slda-device was snared and pulled back to the tip of a 26f gore dry seal sheath, and it was successfully extracted.The procedure to treat the tr continued with a new pascal guide sheath and pascal aces.Two pascal aces were placed, both in the anterior-septal position and the tr grade was reduced from 5+ to 2+.

Manufacturer Narrative

The presence of dislodging/disturbance of previously implanted devices as described in the complaint event was confirmed with objective evidence through imaging evaluation.Based on review of procedural images and investigation findings, potential contributing factors to the dislodging/disturbance of previously implanted devices are procedural conditions (post-procedural slda, targeted trajectory, and pascal ace positioning between previously implanted pascal aces), as well as device maneuverability.The reported dislodging/disturbance of previously implanted devices event does not allege a malfunction that could be related to an edwards manufacturing deficiency, and one was not confirmed per imaging review.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: 18837419
• MDR Text Key: 336898263
• Report Number: 2015691-2024-01585
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)250107
• 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: 04/12/2024

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: 11596809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2024
• 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 Sex: Male