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

Model Number 20000ISM

Device Problem Entrapment of Device (1212)

Patient Problem Cusp Tear (2656)

Event Date 06/27/2023

Event Type  Injury  

Event Description

Edwards received notification of a pascal precision ace in tricuspid position where the device was prepared according to the manual.The implant was advanced into the right la and after clasp check and rotation it was successfully advanced into the rv.There was a good position and it was tried to grasp the a-s central.The first grasp did not reduce the tricuspid regurgitation (tr), so another position was tried.After grasping the anterior leaflet first, the physician rotated the handle to reach the septal leaflet.The rotation was from 2o'clock to 5o'clock, but then the leaflet perforated and there was a hole in the anterior leaflet.Because of the hole, the implant was bailed out and the patient left the or without anesthesia.No actions were taken.A surgical treatment will be discussed.Starting tr was grade 3 and post procedural tr grade 4.As per medical opinion, the patient underlying conditions (fibrotic valve) may have played a role.The mv already received a replacement.First it was tried to reconstruct it (mitral valve), but because of a fibrotic valve, the surgeon had to replace it with a mechanical valve.

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.H3 other text : not returned.

Manufacturer Narrative

The complaint for leaflet damaged while capturing was confirmed with objective evidence via the imagining evaluation and the testimony of the edwards on-site clinical specialist.No manufacturing non-conformities were identified from the imaging evaluation.Available information suggests that patient conditions (scalloped/thickened leaflets, multiple eccentric jets, and mvr) may have contributed to the reported event of damaged leaflet.

Manufacturer Narrative

The following sections have been added/updated/corrected: b4, b5, g3, g6, h2 and h10.

Event Description

Additional information received stated that the patient was surgically treated with a 32mm edwards tricuspid ring.The anterior leaflet was sewn on and the patient left the hospital with a tr of 1-2.

• 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: 17361852
• MDR Text Key: 319403710
• Report Number: 2015691-2023-14691
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)240517
• 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,Followup
• Report Date: 08/23/2023

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: 05/17/2024
• Device Model Number: 20000ISM
• Device Catalogue Number: 20000ISMA
• Device Lot Number: 10844271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 08/10/2023; 08/22/2023
• Supplement Dates FDA Received: 08/10/2023; 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2023
• 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