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

Model Number 9610ES14

Device Problem Difficult to Advance (2920)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/23/2022

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 26mm sapien 3 ultra valve, there were difficulties inserting the valve through the esheath, and a lot of push force had to be used.Upon removal of the delivery system and esheath, it was noted that the devices were very angled and curved due to the patient anatomy.A femoral angiogram showed vessel occlusion at the access site where the non-edwards closure device was used.The team decided to crossed with a wire and a balloon was used to open the vessel, and good flow was achieved.There was no device damage or edwards device malfunction.The curve was due to the patient anatomy.Per medical opinion, the perceived root was a combination of calcium in common femoral artery (cfa), high puncture, and the non-edwards closure device with a combination of high push force used to pass the valve through the e-sheath.The patient was doing well, and the procedure went well with a good result.

Manufacturer Narrative

Correction to section h6.Per the instructions for use (ifu), coronary flow obstruction is a known potential adverse event associated with the tavr procedure.The ifu cautions that safety and effectiveness have not been established for patients with bulky calcified aortic valve leaflets in close proximity to coronary ostia.In addition, it warns that caution should be exercised in implanting a bioprosthesis in patients with clinically significant coronary artery disease.Coronary obstruction can result in myocardial ischemia or infarction due to obstruction of the coronary blood flow and may require intervention (e.G.Percutaneous coronary intervention (pci)).The esheath was received with a dilator inserted with liner fully expanded and tip opened as designed.The delivery system was returned with loader cap assembly inserted and stopcock and atrion.Delivery system returned in lock position.Fine adjustment 0% used.Flex indicator in straight position.Stopcock difficult to remove.Atrion device with 24ml of saline liquid; kink in the guidewire lumen due to packaging; the balloon was fully inflated with no leaks observed.No abnormalities were observed on the returned balloon.The esheath was visually inspected upon return and the following was observed: curvature noted on sheath shaft; sheath liner was expanded as designed; sheath distal tip opened as designed; scratches observed on the sheath.A review of imagery provided showed tortuous anatomy observed as delivery system passes through patient anatomy.A device history review (dhr) was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.A lot history review was performed and revealed no additional similar complaints relating to frame damaged during use.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.A review of the risk management documentation was performed, and 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 was confirmed per evaluation of the returned device.However, no manufacturing nonconformance was identified during evaluation.Review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaints.A review of manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were noted during device unpacking or preparation.Per report, ''there were difficulties to push the valve through the esheath and a lot of push force had to be used.The loader was fully inserted into sheath and the delivery system was up to first white line as per ifu recommendations when inserting valve/loader into sheath.After removing the delivery system and sheath, it was noted that the devices were very angled and curved due to patient anatomy but no device damage or malfunction.'' per the ifu/training manual, ''push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification.'' per the case notes, calcification was present in the patient's access vessel.In addition, tortuous anatomy was observed in procedural imagery provided.Tortuosity can create sub-optimal angles that can lead to non-coaxial alignment between the devices in the advancement of the delivery system through the sheath.Calcification can reduce the vessel lumen diameter and may increase restriction leading to resistance.Both of these patient factors could increase resistance, leading to difficulty advancing the delivery system through the sheath.Scratches observed on the sheath are also indicative of calcification.As such, available information suggests that patient factors (calcification, tortuosity) may have contributed to the complaint event.In this case, the vessel occlusion cannot be confirmed, however, maybe related to patient/procedural factors.Since no manufacturing non-conformances or labeling/ifu/training deficiencies were identified, no corrective/preventative actions are required.A product risk assessment (pra) 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.

• 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: 14119456
• MDR Text Key: 289347677
• Report Number: 2015691-2022-05155
• 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: 06/20/2022

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: 09/08/2023
• Device Model Number: 9610ES14
• Device Lot Number: 64188729
• 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: 03/23/2022
• Initial Date FDA Received: 04/15/2022
• Supplement Dates Manufacturer Received: 06/17/2022
• Supplement Dates FDA Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2021
• 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: 80 YR
• Patient Sex: Female