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

Model Number 914ESJ

Device Problem Material Puncture/Hole (1504)

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

Event Date 05/31/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.Device was discarded.

Event Description

As reported by our japan affiliate, during a transfemoral tavr procedure with a 26mm sapien 3 valve, there was the sound of something tearing noticed when inserting the delivery system into the 14f e-sheath.The tearing sound was heard when the valve exited the esheath tip.However, since there was no change on the fluoroscopy image, it was decided to proceed.There was no difficulty experienced when inserting the delivery system through the esheath.The valve was implanted without any problem.After that, when the delivery system was about to be removed from the patient's body, there was a finding on the fluoroscopy image that the delivery system was protruding from fully expandable part of the sheath.Therefore, the delivery system was slowly returned into the sheath and removed while confirming the fluoroscopy image.The procedure was completed successfully with no vascular damage.When the sheath was checked postoperatively, the seam was completely peeled, and the delivery system probably protruded from the peeled seam.-all fully expandable part of the sheath was opened-.In the physician-s opinion, the event occurred during insertion of the delivery system in the esheath.The noise during delivery system insertion may have been the sound of the seam being peeled.

Event Description

As reported by our japan affiliate, during a transfemoral tavr procedure with a 26mm sapien 3 valve, there was the sound of something tearing noticed when inserting the delivery system into the 14f e-sheath.The tearing sound was heard when the valve exited the esheath tip.However, since there was no change on the fluoroscopy image, it was decided to proceed.There was no difficulty experienced when inserting the delivery system through the esheath.The valve was implanted without any problem.After that, when the delivery system was about to be removed from the patient's body, there was a finding on the fluoroscopy image that the delivery system was protruding from fully expandable part of the sheath.Therefore, the delivery system was slowly returned into the sheath and removed while confirming the fluoroscopy image.The procedure was completed successfully with no vascular damage.When the sheath was checked postoperatively, the seam was completely peeled, and the delivery system probably protruded from the peeled seam.-all fully expandable part of the sheath was opened-.In the physician-s opinion, the event occurred during insertion of the delivery system in the esheath.The noise during delivery system insertion may have been the sound of the seam being peeled.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings.Sections b4, g3, g6, h2, h6: type of investigation, investigation findings, investigation conclusions and h10 has been updated.The device was not returned to edwards lifesciences for evaluation.A review of the post-procedural device image provided shows the introducer protruding through the esheath liner mid-shaft.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 this event is not required at this time.The complaint was confirmed from the provided imagery.However, without the returned device, engineering was unable to perform any visual, functional, or dimensional testing.Therefore, a manufacturing non-conformance was unable to be identified as contributing the event.A review of the device history records (dhr), lot history, and complaint history showed no indication a manufacturing/design defect contributed to the event.A review of the ifu/training manual was performed and no deficiencies were identified.Furthermore, there was no report of any issue with the sheath during device unpacking or preparation.As reported, -after that, when the delivery system was about to be removed from the patient's body, there was a finding on the fluoroscopy image that the delivery system was protruding from fully expandable part of the sheath.[-] when the sheath was checked postoperatively, the seam was completely peeled, and the delivery system probably protruded from the peeled seam.All fully expandable part of the sheath was opened-.Imaging evaluation confirmed that the liner was damaged.As mild tortuosity was present in the access vessel, it is possible that the non-coaxial entry of the delivery system through the sheath resulted in the valve interacting with the liner and thereby damaging it upon entry.Additionally, it is possible that non-coaxial withdrawal of the delivery system through the sheath could have resulted in liner damage as well.As such, it is possible that patient factors (tortuosity) may have resulted in a damaged liner and the delivery system with crimped valve to protrude from the sheath.However, a definite root cause could not be determined 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.No corrective or preventative actions are required.There were no manufacturing non-conformance and no ifu/training manual deficiencies identified during this evaluation.Therefore, no corrective action or preventative and no product risk assessment escalation 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: 14807522
• MDR Text Key: 302009024
• Report Number: 2015691-2022-06391
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103194838
• UDI-Public: (01)00690103194838(17)231124(10)64120997
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2023
• Device Model Number: 914ESJ
• Device Lot Number: 64120997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• 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: 80 YR
• Patient Sex: Male
• Patient Weight: 68 KG