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

Model Number 20000ISMA

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Rupture (2208); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 09/15/2023

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.H3 other text : not returned.

Event Description

Edwards received notification of a pascal in mitral position where there was a suspected leaflet injury.There were imaging challenges and dense chordal regions were identified during the case.Chordae damage was identified after multiple grasp attempts with the ace, as second implant.Standard troubleshooting measures, elongation were used to navigate away from the chordae.The implant was moved more medially, away from the suspected injury.Baseline mr was 4 and post op mr was also 4- severe.

Manufacturer Narrative

The following sections were updated/corrected/added: b4, d4, g3, g6, h2, h4, h6 and h10.The complaint for chordae damaged in attempt to capture leaflet was confirmed with other empirical evidence.No manufacturing non-conformities were found as a result of the complaint evaluation.Available information suggests that patient factors (dense chordal regions, chordal interaction, mild thickening of aml/pml, tethering of pml), and procedural use (imaging challenges, a multiple individual leaflets grasping attempts and optimizations of both leaflets aml and pml) contributed to this adverse 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: 17913932
• MDR Text Key: 325410083
• Report Number: 2015691-2023-16710
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103216950
• UDI-Public: (01)00690103216950(17)240802
• 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: 11/02/2023

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: 11083205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/11/2023
• Supplement Dates Manufacturer Received: 11/01/2023
• Supplement Dates FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2023
• 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