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

Model Number 914ESPA

Device Problem Material Integrity Problem (2978)

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

Event Date 07/08/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by field clinical specialist, a patient successfully underwent a transfemoral tavr procedure with a 23mm s3 ultra valve in the aortic position.During removal of the esheath, the physician noticed the sheath was "damaged/frayed" horizontally at the distal tip at the radiopaque marker.There was no difficulty noted inserting the sheath into the patient and no difficulties noted inserting the delivery system through the sheath.The physician did not experience any withdrawal difficulty.There was no abnormalities noted along the liner and/or shaft after removing the esheath from packaging or during prep.There was no harm to the patient.Surgical cutdown was the initial primary access.Dilator was not used during sheath removal.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings.Sections b4, d9, g3, g6, h2, h3, h6: type of investigation, investigation findings, investigation conclusions and h10 has been updated.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 sheath distal tip torn was confirmed per evaluation of the returned device.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, -during removal of the esheath, the physician noticed the sheath was "damaged/frayed" horizontally at the distal tip at the radiopaque marker.There was no difficulty noted inserting the sheath into the patient and no difficulties noted inserting the delivery system through the sheath.The physician did not experience any withdrawal difficulty.There was no abnormalities noted along the liner and/or shaft after removing the esheath from packaging or during prep.- per evaluation of the returned device, the sheath distal tip was observed to be torn radially along the distal edge of the liner.The failure mode is characteristic of sheath tip tear events.While a definitive root cause was unable to be determined, previous investigation indicated that the tear is attributed to improper tip expansion, resulting in interference between the valve and sheath tip.As such, it is possible that improper tip expansion contributed to the experienced delivery system advancement resistance at the sheath distal tip and the distal tip tear.Additionally, 3mensio imagery was also provided and shows the presence of access vessel tortuosity near the aortic bifurcation.Per the training manual, -push force can vary due to angle of access and insertion, thv size, vessel diameter, tortuosity and degree of calcification-.Tortuosity can lead to non-coaxial alignment between the crimped valve and the sheath, which may lead the valve struts to catch onto the sheath distal tip, tearing the tip.As such, the failure mode may be related to improper expansion of the sheath tip during thv advancement and/or patient factors (tortuosity) may have contributed to the complaint events.However, a definitive root cause was unable to be determined at this time.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.

• 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: 15154548
• MDR Text Key: 301943185
• Report Number: 2015691-2022-07121
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)240315(11)2203162164278155
• 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: 10/19/2022

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: 03/15/2024
• Device Model Number: 914ESPA
• Device Catalogue Number: 914ESPA
• Device Lot Number: 64278155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/08/2022
• Initial Date FDA Received: 08/03/2022
• Supplement Dates Manufacturer Received: 10/15/2022
• Supplement Dates FDA Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2022
• 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 Age: 77 YR
• Patient Sex: Female