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

Model Number 914ESPA

Device Problems Difficult to Advance (2920); Material Twisted/Bent (2981)

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

Event Date 01/25/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted when additional information is provided.

Event Description

During the implantation of a 23mm sapien 3 ultra valve in the aortic position, resistance was noticed while advancing the delivery system through the sheath.It was noticed that the distal end of the sheath had unraveled during the delivery system advancement.There were no adverse outcomes or extra time and no unusual calcium in this patient.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings.Sections g6, h2 h6: component codes, type of investigation, investigation findings, investigation conclusions and h10 has been updated.The device was not returned for evaluation.An image review was performed on imagery provided of the patient's anatomy and the following was observed: the sheath distal tip was shown to be torn and slightly attached to the shaft.Distal tip did not open along axial score line as designed and liner expanded as designed.Distal tip tear events on the esheath for a comprehensive comparison to the esheath plus have been previously investigated by edwards and documented in clinical technical summary written by edwards lifesciences.The distal tip component and manufacturing process for the esheath and esheath plus are identical.As the device was not returned, engineering was unable to perform any visual inspection, functional testing, or dimensional testing.A device history record (dhr) review was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review was performed and revealed no other complaints relating to the complaint.The esheath plus ifu, preparation training manual and procedural training manual provide guidance for directions for use, sheath introducer set preparation and sheath insertion.No ifu/training deficiencies were identified.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 the failure mode is not required at this time.The complaints for sheath distal tip torn and difficulty advancing the delivery system through sheath were confirmed per evaluation of device imagery.However, no manufacturing nonconformance was identified during evaluation.Review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaints.A review of manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were noted during device unpacking or preparation.Per the complaint description, "the distal end of the sheath unraveled.There was resistance noticed while advancing the delivery system".Per evaluation of received imagery of device, the sheath distal tip was observed to be torn along the distal edge of the liner.A pra was previously initiated to investigate the cause and assess the risk associated with radial tip tearing on the esheath.While a definitive root cause was unable to be determined, investigation documented in the pra indicates that the tear may be possibly attributed to improper tip expansion, resulting in interference between the valve and sheath tip.As such, it is possible that this interaction contributed to the experienced delivery system advancement resistance at the sheath distal tip and the distal tip tear.A capa was previously opened to capture potential process improvement activities regarding tip expansion which were identified during the investigation.

• Brand Name: ESHEATH PLUS INTRODUCER SHEATH
• 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: 13509429
• MDR Text Key: 285745694
• Report Number: 2015691-2022-03878
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)231101(11)2111012164076031
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2023
• Device Model Number: 914ESPA
• Device Catalogue Number: 914ESPA
• Device Lot Number: 64076031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• 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