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

Model Number 9610ES14

Device Problems Difficult to Insert (1316); Material Split, Cut or Torn (4008)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 06/29/2022

Event Type  Injury  

Manufacturer Narrative

Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

As reported by our edwards affiliate in france, during a transfemoral tavr procedure, some difficulties were encountered during the insertion of a 14fr esheath.As the sheath was being inserted, the threads of the closing system (4 threads / 2 systems) were moved.Following sheath placement, a 20mm sapien 3 valve was successfully implanted.Following the removal of the sheath, the closure threads could not be used to close the artery.Two more closure devices were used.During the attempt to remove the lost threads with guide, the artery was torn.Surgical repair of the artery was performed.At the time of the report, the patient was in stable condition.The valve remains implanted in the patient.

Manufacturer Narrative

Additional information: section h6: adverse event codes; section h10: narrative text.Additional information received indicated the esheath distal tip was split.Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Manufacturer Narrative

The 14fr esheath was not returned to edwards lifesciences for evaluation.Without the device, visual inspection, functional testing and dimensional analysis could not be performed.Applicable case imagery was not provided for review.Device history review (dhr) review was performed for the components most relevant to the reported event.The work orders did not reveal any manufacturing non-conformances that could have contributed to the reported event.Lot history review did not reveal any other related complaints.The complaints for 'interventional device interacts with non-edwards device' and 'difficulty introducing sheath' were unable to be confirmed, while the complaint for 'failure - sheath distal tip split' was empirically confirmed through follow-up information.However, without a returned device or imagery, a manufacturing non-conformance could not be identified nor device testing performed.Review of the dhr, lot history, and complaint history showed no indication a manufacturing non-conformance contributed to the event.No ifu/training manual deficiencies were identified.Additionally, as no device damage was observed during device preparation, it is unlikely the device was damaged out of box.As reported, 'it was felt difficulties to move up esheath in the artery'.Per the ifu, 'this product is contraindicated for patients with tortuous or calcified vessels that would prevent safe entry of the dilators and sheath'.Also, the patient's access vessels were observed to be minimally tortuous and moderately calcified, both of which were identified in the complaint history review as potential causes.The presence of calcification and tortuosity can create a challenging pathway for sheath insertion, as calcification can create friction and damage through contact with the sheath, while tortuosity can subject the sheath to suboptimal angles.Additionally, it is possible that combined with interaction with access vessel characteristics, the sheath was excessively manipulated to overcome the resistance experienced during sheath insertion, contributing to the splitting of the sheath distal tip.However, without an image of the device post-procedure, the degree of distal tip split is unknown.It was also reported that, '[during sheath insertion] the sheath moved threads of the closing system (4 threads / 2 systems).At the moment of closing the artery, it was unable to take the threads.It was decided to install two other closing systems and try to remove the lost threads with guide but the artery had torn and surgery was needed for closing it'.As no imagery was provided pertaining to the noted negative device interaction, the events surrounding the movement of the closure threads is unknown.Although definitive root causes of the reported events were unable to be determined with the limited information provided.Available information suggests in addition to the procedure itself, patient factors (vessel lumen, calcification and tortuosity) may have contributed to the reported events.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 this adverse event is not required at this time.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.No corrective or preventative actions are required.

• Brand Name: EDWARDS EXPANDABLE 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: 15042097
• MDR Text Key: 296065792
• Report Number: 2015691-2022-06825
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2022

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 Expiration Date: 01/26/2024
• Device Model Number: 9610ES14
• Device Lot Number: 64162397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/18/2022
• Supplement Dates Manufacturer Received: 07/26/2022; 09/01/2022
• Supplement Dates FDA Received: 07/28/2022; 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• 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: 72 YR
• Patient Sex: Female