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

Model Number 9610ES16

Device Problems Deflation Problem (1149); Material Integrity Problem (2978); Output Problem (3005)

Patient Problems Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2021

Event Type  malfunction  

Event Description

Edwards received notification from our affiliate in (b)(6).As reported, it was a case of an implant of 29mm edwards sapien 3 transcatheter heart valve.The procedure went well, the valve was well positioned.More volume (+3cc) was used for inflation and valve release, as it was a large ring.There was difficulty removing the balloon through the esheath, as the balloon was not fully deflated (there were remnants of contrast).The balloon got stuck and tore the sheath.At that point, negative pressure was applied to the balloon, and blood was drawn into the syringe, suggesting the balloon had been torn (leakage).At the end of the removal of the 16fr esheath introducer, there was a vascular lesion caused by the sheath that ruptured, the probable cause was that the balloon was not completely deflated and when it was pulled into the introducer, it made a tear.The injury was resolved with a bypass and the patient is recovering well.

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2021-07065 for the vascular injury noted upon removal of the devices.

Manufacturer Narrative

The device was not returned for evaluation as it was discarded.Therefore, a no product return engineering evaluation was performed.Images of the device were received and the following was observed: liner bunching seen near center of sheath shaft.Liner delamination was seen halfway of sheath shaft.Kinks were seen in sheath shaft, likely due to retrieval difficulty.Tortuosity was seen in patient's access vessels.The device history record (dhr) review did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to this event.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 complaint esheath damage and esheath liner delamination were confirmed through returned procedural imagery.No manufacturing non-conformances were identified through evaluation of the returned device.A review of the device history record, lot history, and complaint history support that a manufacturing non-conformance likely did not contribute to the reported event.A review of ifu/training materials revealed no deficiencies.Additionally, there was no report of any issues with the sheath during device preparation or unpacking, indicating that this was not an out of the box issue.Per the complaint details, 'more volume (+3cc) was used for inflation and valve release, as it is a large ring.Balloon was possibly not fully deflated upon removal.' the ifu states that 'the delivery system requires a prescribed volume for thv deployment and proper function.' furthermore, the training manual also states that the inflation balloon should be completely deflated prior to retrieving the delivery system.Additional fluid could alter the balloon profile, causing non-coaxial alignment during removal.This non-coaxial alignment can cause difficulty in device removal.Additionally, tortuosity was seen in the patient's access vessels.Tortuosity creates suboptimal angles that can lead to non-coaxial alignment.With the altered balloon profile and tortuosity, excessive manipulation was likely used to withdraw the device.Excessive manipulation combined with tortuosity likely caused the kinks in the sheath shaft.Additionally, the altered balloon profile likely got stuck onto the sheath, causing the liner to delaminate.As the balloon was stuck on the sheath, the liner also bunched up after delamination.As such, available information suggests that patient factors (tortuosity) and procedural factors (excessive manipulation, altered balloon profile) likely contributed to the complaint event.No ifu/labeling/training manual inadequacies or manufacturing non-conformances were identified.Therefore, no corrective/ or preventative actions nor product risk assessment (pra) are required at this time.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 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: 13084743
• MDR Text Key: 284974480
• Report Number: 2015691-2021-07066
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103193244
• UDI-Public: (01)00690103193244(17)230204(10)63629411
• 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: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2023
• Device Model Number: 9610ES16
• Device Catalogue Number: N/A
• Device Lot Number: 63629411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/04/2021
• 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 Age: 75 YR
• Patient Sex: Male