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

Model Number 20000ISMA

Device Problems Difficult to Advance (2920); Patient Device Interaction Problem (4001)

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

Event Date 08/08/2023

Event Type  Injury  

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).B2: other serious- even though there was no reintervention, there is a potential for reintervention in this case.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Event Description

Edwards received notification of a pascal in mitral position where the 2nd ace implant was prepped successfully and entered patient.Target was medial a2/p2 medial of initial pascal device.After optimization, closing, adjusting position/orientation approximately 5 times while closing implant actuation wire break occurred/was noticed.Implant clasps and paddles not aligned wire visibly unattached to distal nut.Upon discovery of actuation wire break clasps were raised and implant was bailed out by recommended training technique.The p10 was implanted in central to lateral portion of the jet, reducing mr from 4+ to 2+.Focal medial jet remained.Plan was to implant ace in medical jet to p10 but due to shadowing of implanted p10, there was difficulty identifying posterior leaflet capture versus chord capture when attempting ace implant.It was attempted to capture, closed, evaluate 6-7 times to identify the moderate to severely tethered posterior leaflet.When there was decent visualization of posterior leaflet, the clasps were dropped, and attempted to close under fluoro.Dr.(b)(6) questioned the shape of the implant or lack of the implant closing.After a few seconds it was identified that the actuation wire was no longer intact to the distal nut and the implant was unable to close.The clasps had already been dropped on the leaflet, but the bailout was then performed, where the 2+ mr turned to 3+ due to a possible torn chord.Although in the follow up call with the cs, it was noted that a chordal rupture was unlikely in their opinion.The initial implant remained in place and overall, the recapture was successful.The rest of the procedure was aborted, and no further pascal were implanted since the physician was uncomfortable with the actuation wire break and her lack of understanding of the root cause.The following day the mr looked bad, but the pressures looked better overall though down by 1/3rd probably.Patient feels good per the clinical specialist.

Manufacturer Narrative

The complaint for implant advanced too far, resulting in chordal entanglement was confirmed with objective evidence via imaging evaluation.For the observed chordal interaction, imaging evaluation confirmed a posterior chordal interaction without leaflet engagement.Per the complaint description, due to shadowing of implanted p10, there was difficulty identifying posterior leaflet capture versus chord capture when attempting ace implant.Several attempts were made of cycling the implant multiple times, repositioning, and biasing posterior to optimize the posterior capture.Therefore, due to potential imaging issues and procedural maneuvers to optimize posterior capture, chordal entanglement occurred, and bailout was performed.

• 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: 17647016
• MDR Text Key: 322241904
• Report Number: 2015691-2023-15556
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103216950
• UDI-Public: (01)00690103216950(17)240706
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2023

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: 20000ISMA
• Device Lot Number: 10999101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 11/06/2023
• Supplement Dates FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2023
• 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