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

Model Number 916ESPA

Device Problems Material Integrity Problem (2978); Physical Resistance/Sticking (4012)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 02/28/2024

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.H3 other text : the device was discarded.

Event Description

As reported by the field clinical specialist (fcs), during a transfemoral tavr procedure, the access site of the right femoral artery was steep.As the 29mm sapien 3 valve was advanced into the 16 fr esheath+, there was a significant amount of resistance.Under fluoroscopy, it was noted the esheath+ had started to accordion.The 29 mm commander and valve were removed.There was no visible damage noted to the first valve or delivery system.The esheath+ was exchange for a new 16fr esheath+ and a new valve and commander system was prepped.The initial esheath+ was inspected and was shown to have a tear in the non-expandable portion of the esheath+ (at the accordion site).The skirt side of the valve was beyond the loader cap.After the new valve was deployed, there was significant extravasation from the access site of the right femoral artery.A covered stent was placed, however the profunda artery was now occluded.The plan was to observe the patient in the intensive care unit (icu) and bring them to surgery if blood pressure management was not attainable.Once the patient was in the icu, they received 4 units of red blood cells.Per feedback from the fcs, when the second delivery system/valve was inserted, there was resistance.The interventionalist was instructed to apply a bit of back pressure/pull back on the sheath and insert the delivery system.This instruction relieved the resistance.The perceived root cause of the injury to the vessel was the initial access angle.The needle was too steep.All of the devices were discarded.

Manufacturer Narrative

A supplemental report is being submitted for the completed engineering evaluation.Sections b.2, b.4, g.3, g.6, and h.2 have been updated.Corrections have been made to h.6: type of investigation, investigation finding, and investigation conclusion.An addition was added to h.6: component code.The events reported are anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.The device was not returned for evaluation.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Per the technical summary, the ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The complaints for resistance between system components and strain relief damage were unable to be confirmed as no device was returned nor relevant procedural imagery provided.A review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of the ifu/training materials revealed no deficiencies.Furthermore, there was no report of any issues with the sheath during device unpacking or preparation.As reported, ''during a transfemoral tavr procedure, the access site of the right femoral artery was steep.As the 29mm sapien 3 valve was advanced into the 16 fr esheath+, there was a significant amount of resistance.Under fluoroscopy, it was noted the esheath+ had started to accordion.The 29 mm commander and valve were removed.The esheath+ was exchange for a new 16fr esheath+ and a new valve and commander system was prepped.'' in this case, a steep insertion angle was reported, which can result in non-coaxial alignment between the delivery system and sheath leading to resistance.In addition, if excessive manipulation was used to overcome the experienced resistance, it could have caused the sheath (strain relief) to sustain damage, as reported.As such, available information suggests that procedural factors (steep angle of insertion, excessive manipulation) may have contributed to the reported event.No device or labeling problem was identified during the evaluation.Therefore, no further escalation is required.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 PLUS INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18955866
• MDR Text Key: 338304478
• Report Number: 2015691-2024-02188
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215472
• UDI-Public: (01)00690103215472(17)250920(11)230921
• 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,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 916ESPA
• Device Lot Number: 65325422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2023
• 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 Outcome(s): Required Intervention
• Patient Sex: Male