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

Model Number 9610ES16

Device Problems Material Puncture/Hole (1504); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 11/30/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.H3 other text : the device was not returned.

Event Description

As reported, it was a case of an implant of a 29mm sapien 3 valve.During procedure, the commander delivery system with the crimped valve got stuck into the esheath.The patient required intervention.As per pre-decontamination evaluation, sheath liner torn was observed.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected d.9 date returned to manufacturer, h.3 device evaluated by manufacturer, h.6 impact code, device code, investigation conclusions and investigation findings.Added new information to h.6 type of investigation.The device was returned to edwards lifesciences for evaluation and the following was observed.Crimped valve stuck in sheath shaft at 9cm from strain relief.Sheath liner partially expanded (until 5cm from distal tip) and distal tip unopened.Crimped valve was released by engineering and one bent strut outwards at outflow side.Sheath shaft kinked at valve location.Liner tear with 21cm in length from strain relief.Imagery was not provided for review.A review of the risk management documentation was performed, and no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaints were confirmed based on the evaluation of the returned device.A review of dhr, lot history and complaint 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.As reported, ''during procedure, the commander delivery system with the crimped valve got stuck into the esheath.As per pre-decontamination evaluation, it was observed the following: sheath liner punctured and crimped valve with strut slightly bent at outflow side.'' per evaluation of the returned device, the valve was stuck in the sheath shaft.In this case, it is possible that one or more patient/procedural factors, such as access vessel calcification, tortuosity, undersized vessel diameters, and/or steep insertion angle of insertion, may have been present during the procedure and could have contributed to the complaint event.However, due to insufficient information, a root cause was unable to be determined at this time.Per evaluation of the returned device, a liner tear and one bent strut outwards at outflow side were observed.In this case, it is possible that additional device manipulation to overcome the reported resistance may be applied during the procedure resulting in damage to the sheath.During delivery system advancement through a challenging pathway, it is possible that the devices may not be coaxially aligned.This can lead to the crimped valve to catch onto the liner and lead to damage.Excessive device manipulation applied to overcome the resistance can further damage the sheath through continued interaction between the crimped valve and sheath.As such, available information suggests that procedural factors (valve caught on liner, excessive manipulation) may have contributed to the complaint event.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.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• 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: 18484931
• MDR Text Key: 332563399
• Report Number: 2015691-2024-00238
• Device Sequence Number: 1
• Product Code: DYB
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610ES16
• Device Lot Number: 65220844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2023
• 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 Outcome(s): Required Intervention