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

Device Problem Material Puncture/Hole (1504)

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

Event Date 08/18/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by an edwards australia affiliate, during a transfemoral tavr procedure with a sapien 3 valve, the esheath split open, and the valve went through approximately 10cm from esheath tip during insertion.The valve was implanted successfully.The patient was a severe left heart failure compromised patient in an emergency case.There was no injury to the patient.

Manufacturer Narrative

Correction to h6 based on additional information.The device was not returned to edwards lifesciences for evaluation, however, a device history record (dhr) review was done, and did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed, and 1 related event was confirmed.There was no manufacturing non-conformances that would have contributed to the reported event identified.3mensio imagery and a post-procedural video were provided by the facility, and the following was noted: the delivery system with crimped valve was exposed through the sheath torn liner.The patient's access vessel had presence of calcification and tortuosity.The instructions for use/training manuals were reviewed for guidance/instruction involving the esheath and delivery system usage.Based on the review of the ifu/training manuals, no deficiencies were identified.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 for liner punctured was confirmed based on provided imagery.As the device was not returned, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.As no damage on the sheath was observed or reported during device preparation, the liner damage was likely not present out of the packaging.As reported, 'during procedure on advancement of the valve through e-sheath, sheath split open with valve going through approximately 10cm from e-sheath tip.' per the provided imagery of the patients' vessels, calcification and tortuosity was noted.Calcification can directly damage or weaken the sheath liner.Tortuosity can lead to non-coaxial alignment between the delivery system with crimped valve and sheath inner lumen, which may have led to the crimped valve to catch onto the sheath liner and tear it.As such, available information suggests patient (calcification, tortuosity) and procedural (valve caught on liner) factors may have contributed to the event.However, a definitive root cause is unable to 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.

• Brand Name: EDWARDS ESHEATH INTRODUCER
• 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: 15423419
• MDR Text Key: 305883655
• Report Number: 2015691-2022-07901
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 63 YR
• Patient Sex: Male