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

Model Number 9610ES14

Device Problem Difficult to Advance (2920)

Patient Problem Obstruction/Occlusion (2422)

Event Date 10/18/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.H3 other text : the device was discarded.

Event Description

As reported, it was a case of a 23mm sapien 3 ultra valve, in aortic position by right transfemoral approach.During procedure, resistance and high push force were noted when the delivery system was inserted through the 14f esheath.The valve was implanted with excellent result and system was removed without any problems.On final peripheral vascular angiogram, it was noted that there was an abrupt arterial obstruction at right common femoral artery level just above the right femoral head.Therefore, femoral artery angioplasty was performed with good result and return of blood flow.The patient was stable throughout with good hemodynamics and good vascular perfusion.As per medical opinion, femoral dissection and occlusion due to thv high push force advancing through the esheath at diseased femoral artery.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected h.6 investigation conclusions and investigation findings.Added new information to h.6 type of investigation.The device was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.Imagery was provided from the site and revealed the following: presence of undersized vessel in patient's access vessel (right side).The 14f esheath is indicated for use with vessel lumen diameters less than or equal to 5.5mm.Presence of calcification in patient's access vessels.A review of the risk management documentation was performed, and no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaint was unable to be confirmed without return of the device or relevant imagery.As reported, ''during procedure, the delivery system was inserted successfully through the 14f esheath, but with resistance and high push force''.Patient with diffused vascular disease in both iliacs and femoral arteries.Both access points were severely calcified with localized false lumens and borderline calibers (5.4mm minimum vessel diameter).'' per review of provided 3mensio imagery, the patient's access vessel was undersized (5.4mm) and had presence of calcification.The 14f esheath is indicated for use with vessel lumen diameters less than or equal to 5.5mm.Calcification can reduce the vessel lumen diameter and may increase restriction leading to resistance.Calcification can also result in the creation of sub-optimal angles during delivery system insertion that may lead to resistance.Undersized vessels (e.G.Due to anatomical variation, pre-existing stent or graft, scar tissue, or fibrosis) can create a restricted pathway or constrained condition resulting in difficulty during sheath expansion and increased resistance during the advancement of the delivery system.Available information suggests patient factors (calcification, undersized vessel) likely contributed to the event.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 ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• 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: 18106691
• MDR Text Key: 327865840
• Report Number: 2015691-2023-17373
• 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
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610ES14
• Device Lot Number: 64724362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2022
• 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: 74 YR
• Patient Sex: Male