MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS ESHEATH PLUS INTRODUCER SHEATH; INTRODUCER, CATHETER

Model Number 914ESPA

Device Problems Peeled/Delaminated (1454); Material Integrity Problem (2978); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)

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

Event Date 03/21/2024

Event Type  malfunction  

Manufacturer Narrative

This is one of two reports.Investigation is ongoing.

Event Description

As reported by a field clinical specialist (fcs), during a tavr procedure with a 26mm sapien 3 ultra resilia valve in the aortic position, the valve was damaged while advancing through the esheath+.Frame was damaged and the entire system was removed.Upon follow up, the fcs advised that there were no abnormalities noted on the sheath prior to use.The loader was able to be fully inserted into the sheath and the sheath was not inserted at a steep angle.The delivery system was at the sheath shaft when the resistance was noted.They pre-dilated the vessel with both 14 fr and 16 fr dilators.The devices that were damaged were the valve and the sheath.The fcs advised that the valve prongs prolapsed through and out of the skirt.Upon further investigation, the fcs described the damage to the sheath as well as sent more pictures of the sheath.The sheath had 'small puncture holes, sheath is curved, stretched/split from advancing the valve and dilapidated.'.

• Brand Name: EDWARDS ESHEATH PLUS INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 19085050
• MDR Text Key: 340569055
• Report Number: 2015691-2024-02749
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)251018(11)231019
• 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: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 914ESPA
• Device Lot Number: 65362468
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/19/2023
• 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: Male