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

Model Number 20000ISM

Device Problems Off-Label Use (1494); Difficult to Advance (2920); Mechanical Jam (2983)

Patient Problem Rupture (2208)

Event Date 02/06/2023

Event Type  Injury  

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).Outcomes attributed to adverse event: other serious- tissue damage.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, addressing degenerative mitral regurgitation.Therefore, deployment in the tricuspid position is considered off-label.

Event Description

Edwards received notification of a pascal in tricuspid position where while implanting the 3rd pascal device, the echo showed that gs was accidently pulled back into ivc while retracting implant system number two.Gs was unflexed and advanced into ra again at level of tip of the ridge.There was steering down of third device under echo and fluoro control.While trying to maneuver to posterior septal position several times it entangled with lead in ra and rv or first ace implant.This was solved each time by elongation and retraction in ra.During these attempts at least three times the ic steered into cs- followed by immediate correction.Last correction of the entanglement in rv, echo noticed that system was stuck in ra at the height of the ridge.The device was in elongated position clasp up.The clasp was started to advance and it seemed that device was attached with a structure at one of the retention elements.Gentle movement of clasp was performed, rotation of implant catheter to see if this freed the device, gentle opening and closing and retracting and advancing.First nothing happened but then the device jumped, and hcp said he could turn ic 360 degrees but device still stuck at some structure (chiari network).Clasp was then no longer movable.Hcp then decided to retract is into gs and bail out with knowing that the structure the device was attached to would rupture.There was slow controlled pulling back of is into gs.Everything was removed within the gs and decision was made to stop the procedure.Final result was tr 4.Patient was stable.Other possible solutions need to be found to treat the residual tr.

Event Description

After image evaluation review, there appeared to be device interaction with anatomy/damage to anatomy of the 3rd ace device during device repositioning in the right atria in the procedural tee.There were two pascal ace devices deployed.The second ace device appeared to be in a stable position.The 3rd ace device appeared successfully bailed out.Final residual tr appeared semi-quantitatively, 3 - severe.

Manufacturer Narrative

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.

Manufacturer Narrative

The following sections have been added/updated/corrected: b4, d4, g3, g6, h2, h3, h4, h6 and h10.The complaint for unable to elongate implant to reposition/implant caught on anatomy was confirmed with objective evidence.Although the imaging evaluation did not observe the entanglement event or resulting bailout, a sample of tissue was visibly identified on the returned device.This tissue sample confirms the suspected entanglement event.Per the complaint information, the device was repositioned into the ra in the elongated position with the clasps up, which was aligned with the training manual instructions for repositioning into the ra.It is likely that a combination of the following factors led to this complaint event: presence of a pacemaker lead, eustachean ridge, 2 previous devices, and inadequate imaging.No manufacturing non-conformities were identified through this investigation.

• 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: 16464593
• MDR Text Key: 310489139
• Report Number: 2015691-2023-11190
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)240105
• 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: 05/09/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2024
• Device Model Number: 20000ISM
• Device Catalogue Number: 20000ISMA
• Device Lot Number: 10396751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 03/01/2023
• Supplement Dates Manufacturer Received: 03/24/2023; 05/04/2023
• Supplement Dates FDA Received: 03/29/2023; 05/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2023
• 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 Sex: Male