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

Model Number 914ESPA

Device Problem Material Puncture/Hole (1504)

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

Event Date 08/10/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Not returned.

Event Description

As reported by a field clinical specialist, a patient underwent a left axillary access tavr procedure with a 26mm sapien 3 ultra valve in the aortic position.During the procedure, the first valve breached the esheath through the expandable seam during insertion into the patient.The team had not expanded the hole to accommodate the valve as it passed through the sheath.This valve and system were removed and discarded.A new 26 s3 ultra valve was successfully implanted without incident once the team opened the skin wide enough for the valve to pass through.As reported, the breach/puncture happened outside the body.There was no resistance noted.There was no patient injury.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings.Type of investigation, investigation findings, investigation conclusions and h10 has been updated.The device was not returned to edwards lifesciences for evaluation.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this event is not required at this time.The complaint for liner punctured was unable to be confirmed without the returned device or procedural imagery.As the device was not returned, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.However, review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.Furthermore, there was no report of any issues with the sheath during device unpacking or preparation.Per the complaint details, -during the procedure, the first valve breached the esheath through the expandable seam when trying to enter the skin of the patient-.Per the case notes, the approximate angle of insertion was 45 degrees.A steep insertion angle can create a challenging pathway during delivery system insertion through the sheath, as it can lead to non-coaxial alignment between the devices and the crimped valve to catch onto the sheath liner and tear it.In addition, it was reported that -they didn-t make a hole large enough to accommodate the thv as it made the sheath expand-.An inadequate access site can subject the devices to a constrained condition, limiting sheath expansion, and make it more likely for the crimped valve to make contact with the sheath liner.This can lead to the delivery system and valve to puncture through the liner with additional attempts to advance through the sheath.As such, available information suggests that procedural factors (steep insertion angle, inadequate access site) may have contributed to the complaint event.A definitive root cause is unable to be determined.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor pra is required at this time.

• Brand Name: EDWARDS ESHEATH PLUS
• 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: 15349653
• MDR Text Key: 304966486
• Report Number: 2015691-2022-07672
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)240511(11)2205122164371416
• 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
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2024
• Device Model Number: 914ESPA
• Device Catalogue Number: 914ESPA
• Device Lot Number: 64371416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2022
• Initial Date FDA Received: 09/02/2022
• Supplement Dates Manufacturer Received: 10/21/2022
• Supplement Dates FDA Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• 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