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

Model Number 916ESPA

Device Problems Material Puncture/Hole (1504); Physical Resistance/Sticking (4012)

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

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by the edwards field clinical specialist, during a transcatheter mitral valve replacement case through right common femoral vein access, there was difficulty inserting a 29 mm commander with a 29mm s3ur valve into a 16f esheath+.The valve appeared to tear through the esheath+ distal to the semi-expandable portion.Both the delivery system and valve exited through the side of the sheath.It appeared that the valve and the distal end of the commander were outside of the sheath and the sheath appeared to "bow" as attempts were made to further advance the commander and valve.However during removal from the patient, the valve and distal end of the device appeared to be back inside of the sheath and the system and sheath were removed together.A second 29mm commander was prepared with a second 29mm sapien 3 ultra resilia valve which was implanted successfully.There was no patient injury.

Manufacturer Narrative

Updated section h6- type of investigation, findings, and conclusions.The returned sheath was visually examined, and the following was observed: curvature on the sheath shaft.The liner is torn, and the crimped valve is visible through the torn liner.The sheath is expanded, as designed, until approximately 2" distal of the strain relief.The liner is torn; tear is approximately 4" in length.An additional 2" of liner distal to liner tear is expanded as designed.The remainder 2.5" of the sheath liner is unexpanded and distal tip is unopened.All liner thickness measurements met specification.Imagery provided by the site was evaluated and the following was observed: the liner is torn and the valve appears to be exposed through the torn liner.The complaint for resistance between system components leading to inability to advance through the sheath was confirmed based on evaluation of the returned device and provided imagery.It is possible that one or more patient/procedural factors (access vessel calcification, tortuosity, undersized vessel diameters, and/or steep angle of insertion) may have been present during the procedure.However, due to insufficient information, a definitive root cause is unable to be determined.The complaint for liner puncture was confirmed based on evaluation of the returned device and provided imagery.Available information suggests procedural factors (excessive manipulation) likely contributed to the event.During delivery system advancement through a challenging pathway, it is possible that the devices were not coaxially aligned as resistance was reported.This could have led the crimped valve to catch onto the sheath hdpe, liner, and/or strain relief and lead to damage.Applying excessive device manipulation to overcome the resistance could further damage the sheath through continued interaction between the crimped valve and sheath.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.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is 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: 18891271
• MDR Text Key: 337548751
• Report Number: 2015691-2024-01975
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215472
• UDI-Public: (01)00690103215472(17)251204(11)231205
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 916ESPA
• Device Catalogue Number: N/A
• Device Lot Number: 65470079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2024
• Date Device Manufactured: 12/05/2023
• 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 Sex: Female