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

Model Number 9610ES16

Device Problems Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

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

Event Date 05/10/2022

Event Type  malfunction  

Event Description

As reported from our affiliates in germany, during a case involving a 29mm sapien 3 ultra transcatheter heart valve in aortic position by transfemoral approach, the commander delivery system balloon burst during valve deployment towards the end of inflation.Despite the balloon burst, the valve was correctly positioned.During removal of the commander delivery system, it was not possible to retrieve the balloon back into the esheath due to its radial burst.The commander delivery system was removed together with the esheath as a unit without causing an injury.The patient was doing well post procedure.Pre-decontamination evaluation of the returned esheath showed that the distal tip was split and the shaft was damaged.

Manufacturer Narrative

Investigation is ongoing.

Manufacturer Narrative

Updated h3, h6-type of investigation, investigation findings.Corrected h6- component code, investigation conclusions.The device was returned for evaluation.The following observations were noted on the returned sheath: the liner was fully expanded, and the tip opened as designed.The liner was partially delaminated with a length of approximately 32mm from the distal end, and a length of approximately 40mm starting 110mm from the distal strain relief.Hdpe was damaged mid-shaft.The distal tip was split.The complaint for damaged sheath and sheath distal tip split was confirmed.However, no manufacturing non-conformances were identified in the evaluation.As no lot/work order information was provided, review of the dhr and lot history was unable to be performed.However, review of the complaint history showed no indication a manufacturing non-conformance contributed to the event.No ifu/training manual deficiencies were identified.This event reports sheath shaft damage and distal tip split observed during returned device evaluation that has not resulted in a patient harm, or a device failure to perform its function.Also, there was no evidence of product non-conformances or labeling/ifu inadequacies identified in the evaluation.Therefore, it is not included in the risk management file.Edwards continues to monitor complaint history on a monthly basis.Therefore, the review of risk management file is complete, and no further action is required.The returned commander delivery system had a confirmed radial balloon burst.It is likely that in attempts to remove the burst balloon, the altered profile interacted with the sheath tip at the distal end causing the tip to split.If excessive manipulation was used during these maneuvers or anytime during the procedure, the shaft can be damaged.Available information suggests procedural factors (withdrawal of burst balloon, excessive manipulation) contributed to the 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 corrective or preventative actions are required.

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 14937364
• MDR Text Key: 296851325
• Report Number: 2015691-2022-06642
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

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 Model Number: 9610ES16
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 07/06/2022
• Supplement Dates Manufacturer Received: 09/17/2022
• Supplement Dates FDA Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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