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

Model Number 916ESPA

Device Problem Material Puncture/Hole (1504)

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

Event Date 01/16/2024

Event Type  malfunction  

Event Description

As reported by the field clinical specialist (fcs), during a carotid tavr procedure with a 29mm sapien 3 ultra resilia valve, the valve was observed to be 'popping through the sheath as it was advanced through the 16 fr esheath+'.The valve, commander delivery system, and esheath+ were removed as a unit.A new system was prepped and placed in the left carotid, and the valve was successfully implanted without complication.Per pre-deco findings, the crimped valve was observed to be exposed through the torn esheath liner, distal to the strain relief.A liner puncture was also observed.

Manufacturer Narrative

Investigation is still ongoing.

Manufacturer Narrative

This correction supplemental report is being submitted to correct the date in g3 on manufacturing report number 2015691-2024-02814.G3 was submitted with the aware date of january 16, 2024.The correct aware date for that report is march 18, 2024.

Manufacturer Narrative

The event(s) reported is/are anticipated in the risk management documentation for transcatheter heart valve procedures.The device was returned for evaluation.Visual examination was performed, and the following were observed: associated crimped valve is exposed through the torn liner, distal to strain relief.A kink was noted on the sheath shaft approximately 7 inches from the distal tip.There were scratches along with scraped hydrophilic coating noted on the sheath shaft approximately 1 inches from the distal tip.The distal tip is unopened.The sheath is folded near the valve at distal end of the strain relief.The strain relief was removed, and the liner tear starts approximately 1.25 inches from the hub.A liner is torn approximately 3.25 inches from distal end of remaining strain relief.The liner thickness was measured along the liner tear, all measurements were found to be within the specification.The ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.In this case, the complaint for liner punctured was confirmed based on the evaluation of the returned device.As such, available information suggests that procedural factors (insertion angle, excessive manipulation) may have contributed to the complaint event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• Brand Name: EDWARDS ESHEATH+ INTRODUCER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 19098357
• MDR Text Key: 340568416
• Report Number: 2015691-2024-02814
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215472
• UDI-Public: (01)00690103215472(17)250821(11)230822
• 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,Followup,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 916ESPA
• Device Lot Number: 65249437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/22/2023
• 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 Age: 84 YR
• Patient Sex: Male