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

Model Number 914ESPJ

Device Problems Material Puncture/Hole (1504); Physical Resistance/Sticking (4012)

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

Event Date 01/09/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.H3 other text : no information on return of device.

Event Description

As reported by our japanese affiliate, during the tavr procedure of a 26mm sapien 3 ultra resilia valve, insertion difficulty of delivery system was occurred and aortic dissection from ascending to descending aorta was observed and eventually the patient expired.An emergency tavr was performed for an advanced age patient with dialysis.Since the blood vessels in the lower limb were narrow due to calcification, resistance was felt when inserting the esheath+.The esheath+ was removed and balloon angioplasty was performed using a 7 mm balloon to dilate the vessel.A new esheath+ was prepared to and was inserted smoothly.Significant resistance was felt during insertion of the commander delivery system into the esheath+ at external iliac artery.Upon confirming the esheath+ perspective image, it appeared that sapien 3 ultra resilia valve was protruding from the esheath.The decision was made to remove the delivery system along with the esheath as a unit.When checking the removed esheath, it was revealed that the valve protruding from the esheath.The valve exited through a hole in the liner.A balloon angioplasty was performed again.A new esheath was inserted and a new delivery system was advanced smoothly.There was no resistance between delivery system and esheath, but they were unable to track the system through the anatomy.It was difficult to pass the valve against the native aortic valve.The physician tried to apply flex again to pass, but it did not work.There was some tortuosity in the descending aorta and when they tried to push the device, tension was applied to the tortuosity part.Just when the valve was about to pass, the blood pressure dropped to the 30s.The physician pushed the valve up to ascending aorta and bosmin was administered, no reaction was noted.Cardiac massage was started the percutaneous cardiopulmonary support was initiated.As no flow was confirmed the physician suspected a possibility of aortic rupture.Tee showed a pleural effusion and thoracentesis was performed and blood was seen, which also suggested the possibility of an aortic rupture.It was determined that tavi could not continue, the delivery system/valve was retracted into esheath+ and withdrawn.Although aortogram was performed, the location of the rupture could not be determined.An occlusion balloon was placed in the distal aortic arch, and cardiac massage was continued to maintain blood flow to the brain.When the physician performed a second aortogram a dissection between the ascending and descending aorta was revealed.Considering the patient condition, performing thoracotomy was not possible and the patient passed away during the tavr procedure.Per the medical opinion, the heart team does not believe that difficulty/inability in inserting the device contributed to these events (aortic rupture and aortic dissection).It was thought that vascular damage might have occurred because the difficulties crossing the valve through the native annulus, made it difficult to operate the device.There was plaque in the aortic arch.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings, sections g6, h2, h6: type of investigation, investigation findings, investigation conclusions and h10 has been added.The events reported are anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.The device was not returned for evaluation.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Per the technical summary, the ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The complaints for inability to advance through sheath and liner punctured were unable to be confirmed due to no imagery/device provided.An existing technical summary (captures the root cause analysis for complaints evaluated for resistance with delivery system and valve frame damage as a result from increased push force.The root causes identified in technical summary were reviewed and the following were identified as applicable to this event: tortuous patient anatomy can create sub-optimal angles that can lead to non-coaxial alignment between the delivery system with crimped valve and sheath inner lumen.Kinks or curvature along the sheath shaft can be indicative of the presence of vessel tortuosity.As reported, there was some tortuosity in the descending aorta, which suggests that patient's access vessels could have been tortuous as well.Calcification can reduce the vessel lumen diameter and may increase restriction leading to resistance.Similar to tortuosity, calcification can also result in the creation of sub-optimal angles during delivery system insertion that may lead to resistance.Scratches observed on the sheath shaft can be indicative of the presence of calcified nodules within the access vessel.As reported, patient had calcification.The presence of the above factors 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.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) may have contributed to the reported resistance while patient factors (calcification, tortuosity) and/or procedural factors (excessive manipulation) may have contributed to liner puncture.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.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• Brand Name: EDWARDS ESHEATH PLUS INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18631837
• MDR Text Key: 334551304
• Report Number: 2015691-2024-00749
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103217360
• UDI-Public: (01)00690103217360(17)250927(10)65340108
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 914ESPJ
• Device Lot Number: 65340108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2023
• 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): Death
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 53 KG