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

Model Number 20000GS

Device Problems Difficult or Delayed Positioning (1157); Difficult to Insert (1316)

Patient Problem Vascular Dissection (3160)

Event Date 02/26/2024

Event Type  Injury  

Event Description

Edwards received notification of a pascal precision ace procedure in mitral position.There were kinks found on the guide sheath (gs) and steerable catheter (sc) after removal, and a damage was observed in the iliac vein.The patient had a tortuosity in the access vessel, but it was not a concern during the preoperative conference.However, it revealed the actual tortuosity was more severe than expected during the conference and there were difficulties in inserting a guidewire.A super stiff wire was changed to a much softer one.Although there was no difficulty or resistance while advancing the gs (and implant system), some resistance was felt when torquing the handle of gs.The handle of sc did not also turn right after insertion, but resistance got to decrease after the sc came out from the gs.Then, the pascal ace was implanted successfully, and mitral regurgitation (mr) reduced from 3+ to 1+.After removal of the devices, there were found to be kinks on the gs and sc possibly due to the effect of the tortuosity.Additionally, angiography showed a 5cm long damage on the iliac vein at 25cm distal area from the puncture site, which required placements of three stent-grafts for treatment.Hemostasis was achieved and the procedure was completed with confirming stable condition of the patient.

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The following sections were updated/corrected/added: b4, g3, g6, h2, h3, h6 and h11.The complaint for difficult to insert device into patient resulting in tissue damage was confirmed with other empirical evidence.No manufacturing non-conformities were found in the returned sample.Ct recordings were returned as imaging.Per the imaging evaluation (ie), the imager deemed the received ct recordings as insufficient, and an ie could not be performed.There was no allegation of product malfunction reported.Available information suggests that patient factors (the patient had a tortuosity in the access vessel) and procedural context (it revealed the actual tortuosity was severer than expected and there were difficulties in inserting a guidewire.A super stiff wire was changed to a much softer one) likely contributed to the 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: 18955681
• MDR Text Key: 338308790
• Report Number: 2015691-2024-02185
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213331
• UDI-Public: (01)00690103213331(17)240913(10)65384421
• 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: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

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
• Device Operator: Health Professional
• Device Model Number: 20000GS
• Device Lot Number: 65384421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2023
• 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): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 48 KG