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

Model Number 9610ES14

Device Problem Material Perforation (2205)

Patient Problems Perforation (2001); Vascular Dissection (3160)

Event Date 07/29/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by an edwards (b)(4) affiliate, during a transfemoral tavr procedure with a 23mm sapien 3 ultra valve, resistance was felt during insertion of the delivery system and valve into the esheath.A dissection in the femoral artery and perforation was noted due to a breach in the esheath.A covered stent was implanted and the procedure was successful.

Manufacturer Narrative

Correction to h6 based on additional information.The esheath was returned to edwards for evaluation.Visual inspection of the returned esheath showed: the esheath was fully expanded with the tip opened, the esheath liner was torn in two locations: 10cm from the distal tip with a length of 2cm, and a tear 16cm from the distal tip.Damage was also noted along the esheath.Due to the nature of the device, functional testing was unable to be performed.However, dimensional testing was performed on the returned esheath, and the liner thickness measurements met specification.A device history record (dhr) review did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to the reported event were identified.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 complaints for difficulty advancing through sheath and liner punctured were confirmed through evaluation of the returned device.No manufacturing non-conformance that may have contributed to the complaint event was identified.Per event description, 'the femoral was dissected and perforated due to a breach in the esheath' and 'doctors think it may have happened in the passage of the valve inside the introducer.Because in the advancement of the valve they felt a slight resistance greater than the standard.Although from the study of the ct scan performed before the case, no particularities were found on the peripheral vessels in general and in particular in the tract where the damage then occurred.The femoral artery was 5.5mm / 6mm in diameter and there was no calcium, no tortuosity'.Per evaluation of the returned device, the sheath liner was torn.Per ifu/training manual 'push force can vary due to angle of insertion, thv size, vessel diameter, tortuosity, and degree of calcification'.It is possible that a steep insertion angle was applied which may have created non-coaxial advancement between the delivery system, crimped valve, and sheath inner lumen.This would have increased friction between the devices increasing resistance.In such a condition, it is possible that the crimped valve may have then caught onto the sheath liner and tore it during advancement, especially if compounded with excessive manipulation in an attempt to overcome the resistance.However, as no information relating to the insertion angle was provided, this is unable to be conclusively determined.As such, due to limited information provided, a definitive root cause for the reported resistance is unable to be determined at this time.However, available information suggests that procedural factors (valve caught on liner, excessive manipulation) may have contributed to the torn sheath liner.Product risk assessment was previously initiated to investigate the cause and assess the risks associated with high push force of the commander delivery system with s3u through the esheath.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.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: 15298285
• MDR Text Key: 298662966
• Report Number: 2015691-2022-07512
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

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: 02/14/2024
• Device Model Number: 9610ES14
• Device Lot Number: 64215353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/29/2022
• Initial Date FDA Received: 08/25/2022
• Supplement Dates Manufacturer Received: 10/27/2022
• Supplement Dates FDA Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2022
• 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