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

Model Number 916ESPA

Device Problems Material Puncture/Hole (1504); Difficult to Advance (2920)

Patient Problem Perforation of Vessels (2135)

Event Date 05/31/2022

Event Type  Injury  

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.The investigation is ongoing.Devices were discarded.

Event Description

As reported by the field clinical specialist (fcs), during a transfemoral tavr procedure of a 29mm sapien 3 valve, the commander delivery system with valve perforated through the 16fr esheath+ and also through the iliac artery.Additional information received indicated there was resistance felt at the sheath shaft.There was difficulty withdrawing the system.A surgical cutdown was required to withdraw the delivery system with valve.The iliac perforation was treated with a covered stent and the case was aborted.

Manufacturer Narrative

A supplemental mdr is being submitted based on additional information.The following section of this report has been updated: h10 (provide narrative/data).This is one of two manufacturer reports being submitted for this case.Please reference manufacturer report no: 2015691-2022-06369.The investigation is still ongoing.

Manufacturer Narrative

The device was not returned to edwards lifesciences for evaluation.As a result, no visual inspection, functional testing, or dimensional analysis could be performed.Imagery of the patient's anatomy was provided for review.Calcification and tortuosity were observed within the patient's anatomy.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 also performed and showed no indication a manufacturing non-conformance contributed to the event.The instructions for use (ifu)/training manuals were reviewed for guidance/instruction involving the valve, delivery system, and esheath+ usage.Per the ifu and training manuals, it cautions that if a significant increase in resistance occurs when advancing the catheter through the vasculature, stop advancement and investigate the cause of resistance before proceeding.Do not force passage, as this could increase the risk of vascular complications.It also states that push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification.Do not over-manipulate the sheath at any time.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 events for esheath+ liner punctured and difficulty advancing the delivery system with valve through the esheath+ were unable to be confirmed as the device was not returned and no imagery of the device was provided.As a result, a manufacturing non-conformance was unable to be determined.A review of the lot history, dhr, and complaint history showed no indication a manufacturing non-conformance contributed to the event.No ifu/training manual deficiencies were identified.As no damages on the esheath+ were observed or reported during device preparation, the liner damage was likely not present out of the packaging.As reported, 'the commander delivery system with valve perforated through the 16fr esheath+ and iliac artery' and 'additional information received indicated there was resistance felt at the sheath shaft.' per the ifu/training manual, 'push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification.' review of the patient imagery provided showed tortuosity and calcification in the patient's access vessels.Tortuosity can lead to suboptimal angles that may lead to non-coaxial alignment between the delivery system with crimped valve and sheath inner lumen, which may have led to the experienced resistance.Calcification can reduce the vessel diameter and may increase restriction leading to resistance.During the difficulty experienced, it is also possible that excessive manipulation may have been applied, which could have led to the noted protrusion of the delivery system and crimped valve through the liner.In this case, a definitive root cause was unable to be determined; however, available information suggests patient factors (tortuosity and calcification) and/or procedural factors (excessive manipulation) contributed to the event.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 product risk assessment (pra) nor corrective or preventative actions are 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: 14804250
• MDR Text Key: 295067591
• Report Number: 2015691-2022-06367
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215472
• UDI-Public: (01)00690103215472(17)240307(11)2203082164264338
• 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,Followup
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2024
• Device Model Number: 916ESPA
• Device Catalogue Number: 916EPSA
• Device Lot Number: 64264338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• 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 Sex: Male