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

Model Number	20000ISA
Medical Device Problem Codes	Malposition of Device (2616); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/25/2024
Type of Reportable Event	Serious Injury
Additional 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.H6 clinical code: intraoperative cardiac valve injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Event or Problem Description
Edwards received notification of a pascal in mitral position where initially the patient had severe mr, so it was attempted to implant a pascal device central to medial a2p2.Initial device position was at a2p2 central with minimal reduction in mr.It was then repositioned more medial with optimization attempts but were limited due to chordal density.After discussion it was recommended that we attempt an ace device.In an effort to elongate and bailout the pascal device, a ruptured chord was noted after retrieving the device back into the atrium.The device was bailed out successfully and an ace device implanted at medial a2p2 to address the chordal rupture.The patient had a small valve area which did not allow for a second device to address the remaining mr.Decision was made to go with p10 to start, jet spanning across a2/p2 but jet more dominant on medial aspect.It was tried to optimize with p10 but could not get the mr down.The mr remained on the medial aspect.Maneuvering the p10, team believed they had torn a chord with movement on medial aspect.The strategy changed once the torn chord was expected.The ace was deployed slightly medial a2/p2 to address torn chord.A 1 grade reduction was achieved but could not put in another device, gradient was close to 7mmhg pre-release of the ace.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, g3, g6, h2, h6 and h10.Correction being filed for h6 device code which should be malpositon of device.
Additional Manufacturer Narrative
The complaint for implant repositioned too far in ventricle or not elongated resulting in chordal entanglement was confirmed with empirical evidence based on accounts by the edwards clinical specialist present during the procedure.Available information suggests the challenges with chordal density and patient related factors likely contributed to the event due to the patient small vale area and chordal density potentially causing difficulties during repositioning.Based on extensive complaint investigations and reviews, it has been identified that these events are not associated with device malfunctions or manufacturing nonconformances.Chordal entanglement is a known complication associated with the pascal procedure.This has the potential for suboptimal therapeutic outcome, the need for additional intervention, and/or recurrence of regurgitation.These events will continue to be monitored and complaints trending and control limits are managed and assessed.

• Brand Name: EDWARDS PASCAL PRECISION
• Common Device Name: 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: 18760061
• Report Number: 2015691-2024-01225
• Device Sequence Number: 3838325
• Product Code: NKM
• UDI-Device Identifier: 00690103216943
• UDI-Public: (01)00690103216943(17)241206
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P220003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/06/2024
• Device Model Number: 20000ISA
• Device Lot Number: 11499848
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2024
• Supplement Date Received by Manufacturer: 03/07/2024; 03/07/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 03/07/2024; 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown