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

Model Number	20000GSA
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Positioning Failure (1158)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	07/18/2024
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.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 there were challenges with the guide sheath (gs).It was unable to correct for a-p trajectory and gain height as needed despite having adequate gs access.Patient did have a horizontal heart, had to place the patient in a slight left lateral decubitis position.Also suspected possible tortuous anatomy.The physician asked to have the guide sheath evaluated.The system was reset but the issue persisted despite adequate gs insertion.The procedure was completed with 1 pascal and mr (mitral regurgitation) was reduced from severe to moderate/severe.Additional information received from the cs (clinical specialist) stated that there was some discussion on the unresponsiveness of the gs.The physician also felt that due to the wide ap gap, we may have had more tension of the posterior leaflet and potentially a side bite of the leaflet that we were not able to appreciate.There was discussion that the patient may be brought back at a later date for reintervention.The cs inspected the gs with the is still inserted on the back table.The system was intact, he did observe some gs catheter bowing/curvature of the mid to proximal portion.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, g3, g6, h2, h6 and h11.Corrected b1 to be an adverse event only.There was no malfunction observed based on the investigation findings below.The complaint for unable to flex gs was confirmed with other empirical evidence.Based on the event description, there were several anatomical challenges encountered during the procedure.The patient had a horizontal heart, dense chordae and curling of pmvl.Per the physician account, the physician felt the gs did not hold its position when the a-p trajectory was adjusted or when gaining height which are accomplished by a combination of flexing and rotating the gs.At the time of the procedure, the medical team discussed the following potential causes for the difficulties experienced with gs positioning, tension towards the posterior leaflet due to wide ap gap, tortuous anatomy, or a potential device malfunction.Upon evaluation of the device, there were no malfunctions identified that could have contributed to difficulties positioning the gs.The gs flex was normal per the force to flex test conducted.There were no device defects that could impact gs rotation found during the evaluation.Furthermore, the device history record review was completed, and this device passed all manufacturing and sterilization inspections.No nonconformances related to the complaint event were identified.As no device defects were identified it is likely that the difficulties experienced during the procedure were a result of tortuous anatomy and a large ap gap resulting in a high-tension environment.Available information suggests that patient conditions (tortuous anatomy and large ap gap) 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: 19991529
• Report Number: 2015691-2024-06064
• Device Sequence Number: 7075962
• Product Code: NKM
• UDI-Device Identifier: 00690103216967
• UDI-Public: (01)00690103216967(17)250102(11)240103
• 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
• Report Date (Section B): 10/16/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/02/2025
• Device Model Number: 20000GSA
• Device Lot Number: 65519891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2024
• 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: 07/18/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2024
• 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