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

Model Number 9610ES16

Device Problem Material Integrity Problem (2978)

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

Event Date 04/22/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be completed upon completion.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2022-05734.

Event Description

Edwards received notification from our affiliate (b)(6).As reported, this was a case of an implant of 29mm edwards sapien 3 transcatheter heart valve, in the aortic position by transfemoral approach.During the procedure, following balloon deflation, 7 ml of fluid was left in the balloon.The fluid caused the balloon to parachute, which led to difficulty withdrawing the balloon into the esheath and caused a dissection of the iliac artery.The sheath and delivery system were pulled out of the body as one unit.Per images provided, the esheath liner was observed to be delaminated.

Manufacturer Narrative

The device was not returned for evaluation as it was discarded.Therefore, a no product return engineering evaluation was performed.Imagery was provided from the site and the following was observed: the sheath liner was delaminated and bunched at the distal end.The balloon was bunched over the nose cone and exposed through the bunched liner.The sheath appeared curved from use.Procedural cine was returned and showed the delivery system not being fully deflated prior to the removal from deployed thv.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 complaints sheath liner delamination was confirmed by the provided procedural imagery.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing non-conformance could not be determined.However, review of the device history record, lot history, and complaint history did not provide any indication that manufacturing non- conformance would have contributed to the complaint.A review of ifu/training materials revealed no deficiencies.As there was no note of abnormalities during device preparation, it is unlikely that the reported event was an issue out of box.The complaint stated, ''the inability to deflate'' caused the balloon to parachute, causing sheath to split''.Per training manual, delivery system must be fully deflated prior to removal.As the delivery system was unable to complete deflate, residual fluid left inside the balloon can increase the balloon profile and result in difficulties withdrawing the balloon and esheath delamination, as seen in returned imagery.The access vessel was also noted to be mildly tortuous which can influence the angle of retrieval of the delivery system through the sheath.This coupled with the altered balloon profile likely resulted in the delamination.While a definitive root cause is unknown, it is possible that patient (tortuosity) and procedural factors (excessive manipulation, withdrawal of altered balloon profile, residual fluid) contributed to the complaint event.No labeling or ifu inadequacies have been identified.Since no edwards defect was identified, no corrective or preventative action is required.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: 14431969
• MDR Text Key: 293502737
• Report Number: 2015691-2022-05748
• 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: 06/24/2022

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: 11/05/2022
• Device Model Number: 9610ES16
• Device Catalogue Number: N/A
• Device Lot Number: 63505964
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/18/2022
• Supplement Dates Manufacturer Received: 06/23/2022
• Supplement Dates FDA Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/05/2020
• 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: 84 YR
• Patient Sex: Male