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

Model Number 9610ES16

Device Problems Peeled/Delaminated (1454); Material Integrity Problem (2978); Physical Resistance/Sticking (4012)

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

Event Date 06/08/2022

Event Type  malfunction  

Event Description

As reported from our affiliates in colombia, this was a case of a 29mm sapien 3 transcatheter heart valve.During the procedure, as the esheath, delivery system and valve were advanced, there was resistance while advancing through the esheath; however, the delivery system and valve were able to be advanced.During pre-decontamination observation of the sheath, it was observed that the liner was torn and there was a liner strand.

Manufacturer Narrative

Investigation is ongoing.

Manufacturer Narrative

H10: updated h6- type of investigation, investigation findings corrected h6- investigation conclusions the esheath was visually inspected upon return and the following was observed: liner fully expanded and torn along the entire length.Tip opened as designed.Two strands were observed, one at approximately 13 cm from the tip and another one near the strain relief.The complaints for difficulty advancing through sheath, liner torn, and liner strand were confirmed.However, no manufacturing non-conformances were identified during engineering evaluation.A review of the dhr, lot history and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.Furthermore, no abnormalities were observed during device unpacking or preparation.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.Per the complaint description, "during procedure, at the time of advancing the commander system by the esheath, this generates greater resistance, so it was decided to make movements forward and backward, on several times.Then, it was achieved to advance the system of the first non-expandable portion".Per the ifu/training manual, "push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification".Patient vessel characterization was not provided however, if any of the mentioned patient/procedural factors were present they could have created a challenging pathway for advancement of the delivery system.Per evaluation of the returned device, the liner was torn and there was presence of liner strands.It is possible that a valve strut caught onto the liner during advancement.In addition, excessive device manipulation may have been applied to overcome the experienced resistance further tearing the liner and leading to the liner strands.As such, a definite root cause was able to be determined however, it is possible that procedural factors (valve caught on liner, excessive manipulation) may have contributed to the complaint events.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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 15059485
• MDR Text Key: 304133686
• Report Number: 2015691-2022-06864
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

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: 03/13/2024
• Device Model Number: 9610ES16
• Device Catalogue Number: N/A
• Device Lot Number: 64272191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 09/02/2022
• Supplement Dates FDA Received: 09/06/2022
• Date Device Manufactured: 03/14/2022
• 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