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

Model Number 20000ISM

Device Problems Mechanical Jam (2983); Difficult or Delayed Separation (4044)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2023

Event Type  malfunction  

Event Description

Edwards received notification of a pascal precision ace procedure in mitral position where there were issues while releasing the device.Patient had posterior mitral leaflet (pml) flail central lateral.Strategy was to place one device directly in the flail.There was successful grasp of both leaflets lateral a2-p2 with clocking 12/6 and significant reduction of mitral regurgitation (mr).Decision was made to release the device.Before starting the release, fluoro was checked and no tension was observed on the system, no stress to the device.Removed implant cap and removed both sutures without problems.Left hand of the physician fixed the implant catheter and the right hand turned the release knob.Continued to follow the release in fluoro and checked again for any tension on the implant catheter (ic).Started to rotate implant release knob and it was normal for the first 1-5 turns.After 4-5 turns the physician called out that he was experiencing higher resistance on turning the release knob.Continuing releasing and flouro showed the device turning, up to approximately 45 degrees from original location, then quickly flicking back to original position.After the sudden movement of implant, the team confirmed that implant rotation did not affect regurgitation.Continued to remove device and rest of procedure was normal.No influence in result and reduction noted from 4-0.Patient was in stable condition.

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.H7- a recall has been initiated and notifications to affected customers in the eu and emea are ongoing.

Manufacturer Narrative

The complaint for difficult to unscrew and retract implant release knob was confirmed with objective evidence based on the event reported by the edwards clinical specialist on-site during the procedure.Manufacturing non-conformances were found in the root cause investigation and documented.Available information suggests that multiple root causes in the manufacturing procedure, specifically during implant attachment, allowed for this complaint code to emerge.Recommendations to improve the manufacturing assembly process for implant attachment will be addressed in a capa.A pra was also initiated under management discretion due to multiple complaints reported for this issue in a short period of time.Additionally, this pra addresses the increase in severity of harm related to an existing hazardous situation.An fca was initiated to retrieve potentially impacted units in the eu under this number z-2479-2023.

Manufacturer Narrative

The following sections were updated/corrected/added: b4, g3, g6, h2, h6 and h10 h6 device code updated to: difficult or delayed separation.

• 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: 17666910
• MDR Text Key: 322534695
• Report Number: 2015691-2023-15636
• Device Sequence Number: 1
• Product Code: NKM
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20000ISM
• Device Lot Number: 10951804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2023
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 09/21/2023; 11/13/2023
• Supplement Dates FDA Received: 09/22/2023; 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2015691-7/27/23-001-R
• Patient Sequence Number: 1
• Patient Age: 82 YR