MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ESHEATH INTRODUCER SET; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9610ES14

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

Patient Problem Perforation of Vessels (2135)

Event Date 08/15/2022

Event Type  Injury  

Event Description

Edwards received notification from our affiliate in the united kingdom.As reported, this was a case of a 26mm sapien 3 ultra valve, in the aortic position by right transfemoral approach.The esheath 14fr was successfully introduced via guidewire in accordance with the ifu.When advancing the delivery system through the esheath, no abnormal resistance was found.However, when reaching the border between the strain relief and the expandable part of the esheath, it was found on angiography that the valve came out of the esheath.The esheath was spliced open from the very beginning inside the white coating.After some maneuvers, it was possible to pull the system into the esheath and remove the entire system as a single unit.A new 26mm sapien 3 ultra system was taken and the implantation was successfully completed.Post procedure, it was observed that the abdominal part of the aorta was punctured and a stent was implanted.The patient final outcome was good.

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted upon completion.

Manufacturer Narrative

The device was returned for evaluation and an engineering evaluation was performed.The returned device was visually inspected, and the following was observed: the esheath shaft had some curvature.The sheath was expanded, except the last 2cm from the distal.The distal tip was unopened.A liner tear extending 17cm from the strain relief was noted.The liner thickness was measured at three locations along the length of the tear and all measurements were found to meet specification.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 esheath liner punctured was confirmed through evaluation of the returned device.Reviews of the dhr, lot history, and complaint history review did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.Furthermore, there was no report of any issue with the sheath during device unpacking or preparation.Per the complaint description, ''when inserting the commander delivery system with crimped valve through the esheath, no abnormal resistance was found.However, when reaching the border between the strain relief and the expandable part of the esheath, it was seen on angiography that the valve was protruding though the esheath shaft.It seemed like that the esheath ruptured.It tore from the very beginning inside the white coating''.Per imaging evaluation, the delivery system and crimped valve appeared to be outside of the sheath during the procedure.Additionally, it was reported that the ''patient's left and right femoral arteries had minimal kinking and mild non-circumferential calcification''.Provided imagery supports this as vessel tortuosity was present.Per the training manual, ''access characteristics that would preclude safe placement of the sheath such obstructive calcification, severe tortuosity or vessel diameter less than the minimum recommended should be carefully assessed prior to the procedure''.Calcification can create a constrained condition and damage the exposed portion of the sheath liner through immediate cutting/tearing or weakening of it.A weakened liner can tear during advancement of the delivery system.Vessel tortuosity can create suboptimal angles during delivery system advancement through the sheath, where the delivery system and crimped valve can potentially catch onto the sheath liner and tear it upon advancement.As such, available information suggests that patient factors (calcification, tortuosity) may have contributed to the reported event.However, a definitive root cause is unable to be determined at this time.No labeling/ifu deficiencies were identified.Therefore, no corrective or preventative action, nor product risk assessment (pra) is required 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.Per the instructions for use (ifu), cardiovascular injuries such as perforation or dissection of vessels, ventricle, myocardial or valvular structures are known potential adverse events associated with the overall thv procedure and may require intervention.There are several potential etiologies for ventricular perforation during a thv procedure, including perforation by the guidewire, the delivery system, or the transvenous pacer (tvp) lead.Physicians are extensively trained by edwards before they are qualified to use the sapien transcatheter heart valve (thv).Training includes proper guidewire positioning, fixation of the tvp to prevent ventricle perforation, and careful manipulation of devices.Per the procedure didactic, patients with small ventricles are at particularly high risk for ventricular perforation.

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• 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: 15375154
• MDR Text Key: 299448872
• Report Number: 2015691-2022-07746
• Device Sequence Number: 1
• Product Code: NPT
• 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: 11/15/2022

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 Expiration Date: 03/01/2024
• Device Model Number: 9610ES14
• Device Catalogue Number: N/A
• Device Lot Number: 64257186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 09/07/2022
• Supplement Dates Manufacturer Received: 11/14/2022
• Supplement Dates FDA Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/02/2022
• 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 Age: 74 YR
• Patient Sex: Male