MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ESHEATH+ INTRODUCER SET; INTRODUCER, CATHETER

Model Number 916ESPA

Device Problems Material Puncture/Hole (1504); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by the edwards field clinical specialist, during a transcatheter mitral valve replacement case through right common femoral vein access, there was difficulty inserting a 29 mm commander with a 29mm s3ur valve into a 16f esheath+.The valve appeared to tear through the esheath+ distal to the semi-expandable portion.Both the delivery system and valve exited through the side of the sheath.It appeared that the valve and the distal end of the commander were outside of the sheath and the sheath appeared to "bow" as attempts were made to further advance the commander and valve.However during removal from the patient, the valve and distal end of the device appeared to be back inside of the sheath and the system and sheath were removed together.A second 29mm commander was prepared with a second 29mm sapien 3 ultra resilia valve which was implanted successfully.There was no patient injury.

• Brand Name: EDWARDS ESHEATH+ INTRODUCER SET
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18891271
• MDR Text Key: 337548751
• Report Number: 2015691-2024-01975
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215472
• UDI-Public: (01)00690103215472(17)251204(11)231205
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200258
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 916ESPA
• Device Catalogue Number: N/A
• Device Lot Number: 65470079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2024
• Date Device Manufactured: 12/05/2023
• 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 Sex: Female