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

Model Number 20000ISM

Device Problems Device Damaged by Another Device (2915); Device-Device Incompatibility (2919)

Patient Problems Rupture (2208); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 09/11/2023

Event Type  Injury  

Event Description

Edwards received notification of a pascal precision ace in a mitral procedure where the imaging tee was very difficult from beginning with lots of shadowing- the aml and plm very difficult to see, leaflets tips not visible and shadowing from catheters as well.The procedure started as normal.The first pacal precision ace was placed in medial a2ps position and released.Second device was needed to reduce the mitral regurgitation (mr) and still big part of plm was prolapsing.The flail was still present and there was a two-device strategy set at start.The second ace was positioned in elongation next to first ace with same orientation and trajectory.Patient had very dense chords all over aml and plm.As a result, the orientation of the second ace changed, not being parallel to the first ace.The physician tried several times and did many attempts to have the second ace in the right position to the first ace but never succeeded.Chords kept pushing device in the other orientation.Several attempts were made, but none were successful in good grasping with good orientation and mr reduction.The physician had one good grasping with a desired orientation, but a leaflet optimization was needed on both leaflets.During the optimization of the posterior leaflet some movements were done with implant handle such as torquing handle ic with both clasps down which is not recommended, and the clinical specialist (cs) pointed this out to the doctor.Suddenly, the cs noticed on fluoro that the orientation of the second ace was perpendicular to the first ace and very close with another trajectory.The doctor dropped the posterior clasp and cs saw that the clasp hooked on the first device.Cs then asked the doctor to stop and advised him to do gentle movements to free the clasp.Finally, elongation and sutures completely retracted so claps against spacer, gentle maneuver advance and retract ic combined with flex and unflex sc and torquing anterior posterior steerable catheter, freed the device.It was retracted to the atrium and closed.On fluoro the device looked partially open, and it was not behaving like normal.The pascal was not able to fully elongate and when closing it, the pascal did not close fully.In this case, a new flail occurred during maneuvering the implant system from being attached to the previously placed pascal device.The residual/final mr was 3+.It was decided to do a system retrieval and take a new implant system (is).

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).B2: other serious- flail.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

H6 device code was updated to- device-device incompatibility.

Manufacturer Narrative

The complaint for device interaction with previously implanted devices was confirmed with other empirical evidence via the testimony of the edwards on-site clinical specialist, which provided a detailed description of the sequence of the events for this complaint, as well as additional information on the maneuvering of the device.No manufacturing non-conformities were found in the returned sample.Available information suggests that handling of the device (maneuvers against the manuals and ifu) and the patient conditions (valvular anatomy which presented thickened leaflets with lots of tissue and barlow-like behavior with thick chords in the grasping area) and the procedural imaging may have contributed to the device interaction in 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: 17869476
• MDR Text Key: 324903277
• Report Number: 2015691-2023-16517
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2023

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 Model Number: 20000ISM
• Device Lot Number: 11120619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 10/13/2023; 12/07/2023
• Supplement Dates FDA Received: 10/17/2023; 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2023
• 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): Other
• Patient Age: 75 YR
• Patient Sex: Male