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

Model Number 9610ES14

Device Problems Peeled/Delaminated (1454); Failure to Advance (2524); Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2023

Event Type  malfunction  

Event Description

As reported, it was a case of an implant of a 26mm sapien 3 ultra, in aortic position by transfemoral approach.No abnormality was detected in esheath or delivery system (ds) prior to insertion.The esheath was inserted at a steep angle.The vessel was pre-dilated with a 14fr dilator.When the commander ds was being inserted through esheath, the ds got stuck in the non-expandable area of esheath.Moreover, a bent strut was noticed by fluoroscopy.It was decided to withdraw all the system from the patient at the same time.The patient did not suffer any injury due to this event.A new 26mm sapien 3 ultra, esheath and ds were opened and prepared.The procedure was successfully performed, and the patient final outcome was good.As per medical opinion, the perceived root cause of this event might have been a user error.As per pre-decontamination evaluation, it was observed the following: tip unopened, but tip split; liner was found torn and liner strand under strain relief.

Manufacturer Narrative

This is one of three manufacturer reports being submitted for this case.Please reference related manufacturer report no.2015691-2023-17465, reference number: (b)(4).The investigation is ongoing.

Manufacturer Narrative

This is one of three manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2023-17465 and 2015691-2023-18268.

Manufacturer Narrative

The device was returned to edwards lifesciences for evaluation and the following was observed.Sheath shaft curve.Liner partially expanded, 8cm in length from strain relief.Remainder of liner unexpanded.Strain relief damaged at the distal end.Distal tip unopened, but tip split.Soft tip damaged.Scratches were found on sheath shaft hdpe.Sheath shaft was kinked at the distal end of the strain relief.Liner was torn approximately 2.5cm in length at the location of the strain relief damage.Two (2) liner strands observed approximately 0.5cm and 1cm in length at the location of strain relief damage.Imagery was provided from the site and revealed the following: strain relief was damaged.Liner appears partially expanded.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 complaints were confirmed per evaluation of the returned device and provided imagery.The presence of tortuous patient anatomy, calcification and steep insertion angle can create a challenging pathway during delivery system advancement, leading to resistance.More than one of these factors can compound to further exacerbate the patient/procedural conditions and increase the likelihood of encountering resistance during delivery system advancement through the sheath.It is possible that additional device manipulation to overcome the resistance may be applied during the procedure resulting in damage to the sheath.During delivery system advancement through a challenging pathway, it is possible that the devices may not be coaxially aligned.This can lead to the crimped valve to catch onto the sheath hdpe, liner, and/or strain relief and lead to damage.Excessive device manipulation applied to overcome the resistance can further damage the sheath through continued interaction between the crimped valve and sheath.Vessel calcification and/or tortuosity can exasperate the interaction between the crimped valve and sheath.Sharp calcified nodules can directly weaken the sheath shaft making it more susceptible to damage as the delivery system with crimped valve is advanced through.Tortuosity can subject the sheath to suboptimal angles that can lead to shaft kinks.Excessive manipulation can lead to sheath shaft damage (i.E.Kinks, scratches, tip damage) if compounded with vessel calcification and/or tortuosity.Per training manual, ''do not over-manipulate the sheath at any time'', ''do not force sheath'' and ''push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification''.The presence of calcification and tortuosity in patient's access vessels can subject the sheath to suboptimal angles which can lead to non-coaxial alignment and increased interaction between the device and the vasculature.Additionally, calcification can create a constrained condition during sheath insertion, where sharp nodules of calcification can interact with the sheath tip directly and lead to the reported split, especially if compounded with excessive manipulation of the device during its insertion.The technical summary also outlines the extensive manufacturing mitigations in place to detect a defect or nonconformance associated with this issue.There are several 100% in-process inspections (visual) performed in manufacturing process and product verification testing (functional and visual) on a sampling plan basis performed prior to lot release.These inspections and testing support that it is unlikely that a manufacturing non-conformance contributed to the complaint.In addition, assessment of the detailed instructions for use (ifu), device preparation training manuals, and procedural use training manual revealed no identifiable deficiencies.These mitigations (from manufacturing and the ifu/training manual) as identified in the technical summary are still in place to mitigate this issue.As such, available information suggests that patient factors (calcification, tortuosity) and/or procedural factors (steep insertion angle, valve caught on liner, valve caught on strain relief, excessive manipulation) may have contributed to the reported 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: 18301238
• MDR Text Key: 330170211
• Report Number: 2015691-2023-18267
• 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: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610ES14
• Device Lot Number: 64933248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 12/11/2023; 01/25/2024
• Supplement Dates FDA Received: 12/11/2023; 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1