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

Model Number	20000ISA
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	06/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Edwards received notification of a pascal in mitral position where the procedure was aborted following unsuccessful procedural results using an ace and then a p10.The gradients were 9-10 mmhg and the mr reduction was minimal.Upon final assessment following removal of the pascal p10 their appeared to be a new, small flail noted.Mr was unchanged from baseline and the patient was hemodynamically stable.Md was not concerned and believed it was insignificant.There was no treatment required for the patient.No difficulties navigating the device and no dense chordal regions.Patient was inoperable and the ic was going to try to enroll her into a valve replacement trial.As per medical opinion, the perceived root cause of the flail was calcified, degenerative valve, and not device related.
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.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.H3 other text : not returned.
Additional Manufacturer Narrative
The complaint for chordae damaged in attempt to capture leaflet was confirmed with other empirical evidence.The clinical specialist was able to confirm the chordae damage was observed during the procedure.However, it was minimal as no further treatment is necessary, per medical opinion.The patient anatomical conditions and the procedural factors could have caused the chordae damage as the implants were used to treat mr.In addition, no manufacturing non-conformities were identified from the product investigation.Available information suggests that patient conditions (calcification/size/tethering of the leaflets) may have contributed to the reported event.

• 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: 17281587
• Report Number: 2015691-2023-14447
• Device Sequence Number: 3555105
• Product Code: NKM
• UDI-Device Identifier: 00690103216943
• UDI-Public: (01)00690103216943(17)240508
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Report Date (Section B): 08/22/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2024
• Device Model Number: 20000ISA
• Device Lot Number: 10809808
• 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: 06/14/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2023
• 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