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

Model Number 914ESPJ

Device Problem Difficult to Advance (2920)

Patient Problem Vascular Dissection (3160)

Event Date 02/16/2024

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.

Event Description

As reported by our affiliates in japan, during a tavr procedure using a 23mm sapien 3 ultra valve via right transfemoral access, after balloon aortic valvuloplasty (bav) was performed there was resistance from the time of delivery system insertion.The operator pushed the sheath slightly (advanced the sheath into the patient's body).Immediately before the crimped valve exited the sheath, the resistance decreased slightly, and the delivery system came out from the tip of the sheath.After that, a 23 mm sapien 3 ultra resilia valve was deployed at 90:10 aortic/ventricular position with 2 ml less contrast solution than nominal volume, as intended.Valve deployment was performed without problems.After removing the delivery system and sheath, access vessel angiography showed no complications including dissection.When the sheath was checked after the procedure, the seam was found unopened, which was considered to cause the insertion difficulties.Hemostasis could not be achieved well with the perclose device as the perclose device might have been pulled along with the esheath, for which surgical repair and stent placement were performed for an observed dissection and the procedure was completed.Per report, the blood vessel was pre-dilated with a 16fr dilator.The sheath insertion angle was not steep.There was no resistance during balloon catheter insertion.The loader could be inserted into the sheath without problems.There was no resistance during sheath/delivery system removal.The device will be returned for examination.

Manufacturer Narrative

Correction to h6; component code, type of investigation, investigation findings, investigation conclusion.Update to d9.The 14fr.Esheath plus was returned for examination.A visual examination found that the liner is unexpanded and stretched, starting approximately 1" from distal strain relief, and is approximately 7" in length, the liner is partially lifted starting from distal strain relief and is approximately 1.5" in length, distal 2.5" of the liner is expanded as designed, the tip is opened as designed; slight hdpe stretching at distal tip, and scratches were observed along entire length of the shaft.Due to the nature of the complaint, no functional testing was performed.A device history record (dhr) review was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed complaints relating to the complaint code.However, lot history review did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.During the manufacturing process, the following inspections are in place to detect defects related to the complaint events.All inspections are conducted on 100% of units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.The esheath+ ifu, device preparation manual, and device procedural training manual were reviewed.Based on this review, no ifu training 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 reported event of resistance between system components was confirmed based on the evaluation of the returned device and provided imagery.A review of the dhr, lot history, manufacturing mitigations, and complaint 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, no abnormalities were reported during device unpacking or preparation.As reported, "there was resistance from the time of delivery system insertion, and immediately before the crimped valve exited the sheath, the resistance finally decreased slightly, and the delivery system came out from the tip of the sheath.When the sheath was checked after the procedure, the seam was found unopened".Per the provide patient information, "mld: 5.6mm, the accessed vessel: mild calcification with mild tortuosity." in this case, the patient's access characteristics were characterized by the presence of tortuosity and calcified vessels.These patient factors can contribute to the creation of sub-optimal angles during delivery system (ds) advancement, leading to resistance.Calcification may also increase resistance via increased vessel restriction by reducing the vessel diameter.Evaluation of the returned device revealed the presence of a stretched liner up until the last 2.5 inches from the distal tip.Since the customer reported that the experienced resistance decreased only upon the ds/crimped thv exiting the sheath, the possibility of the stretched liner additionally contributing to increased push forces cannot be ruled out at this time.In this case, available information suggests that patient factors (calcification, tortuosity) may have contributed to the complaint event.However, a definitive root cause was unable to be determined.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 (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: 18822132
• MDR Text Key: 336741081
• Report Number: 2015691-2024-01534
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/21/2024

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: 914ESPJ
• Device Lot Number: 65340110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2023
• 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 Age: 85 YR
• Patient Sex: Female
• Patient Weight: 37 KG