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

Model Number 9610ES16

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

Patient Problem Unspecified Vascular Problem (4441)

Event Date 10/03/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported, 29mm sapien 3 case by right transfemoral apas reported by our affiliates in poland, this was a 29mm sapien 3 case in aortic position by right transfemoral approach.During insertion of the delivery system, there were few attempts to move it forward, and few attempts to move it back, both without success.The system stopped in a twisted orientation, in the abdominal aorta above the bifurcation.Physicians wanted to remove esheath and commander as a single device but were unable to as it was not moving as expected.Through a surgical cut-down, surgeons were able to retrieve part of the esheath, which was completely torn the entire length, and part of the commander with the pusher (valve was still in the esheath).The patient was transferred to the operating room where vascular surgeons cut the artery in 10cm length and retrieved the remaining part of the esheath and commander.The system had been blocked on calcifications and artery contraction (spasm).Artery was repaired with the vascular graft.The entire procedure ended up well after 4-5 hours from the beginning of the tavi procedure.Patient was in a good condition post procedure.The procedure was aborted and the patient is scheduled to have a transcatheter aortic valve implantation procedure with an alternative access at a later point.Proach in aortic position.Safari wire was introduced to the lv.Femoral sheath was exchanged to an edwards esheath of 16fr.Successful pre-dilatation was done with an edwards 25mm balloon.When bav was retracted, the commander system with crimped valve was introduced.During the insertion phase, the system stopped in a twisted orientation, in the abdominal aorta above the bifurcation.It was impossible to move the valve forward and, during the attempt to move it back, it also stopped (the valve never exited the esheath).The initial idea was that maybe the esheath was broken in the place where commander stopped.There were few attempts to move it forward, and few attempts to move it back, both without success.Physicians wanted to remove the esheath and commander as a single unit but it was also impossible, because it was not moving like it was expected.Cardiac surgeons decided to make a surgical cut-down and to try to remove the esheath and commander.It was impossible to retrieve the system from the cut made just below the blocked system, and it was also impossible to retrieve the system from the cut made just above the blocked system.Surgeons were able to retrieved part of the esheath, which was completely torn the entire length, and part of the commander with the pusher (valve was still in the esheath).The decision made was to transfer the patient from the cath lab to the or where vascular surgeons with appropriate backup were able to cut the artery on 10cm length and retrieve the remaining part of the esheath and commander.The system was blocked on calcifications and artery contraction (spasm).Artery was repaired with a vascular graft.The entire procedure ended up well after 4-5 hours from the beginning of the tavi procedure.Patient was in a good condition post procedure.The procedure was aborted and the patient is scheduled to have a tavi procedure with an alternative access at a later point.

Manufacturer Narrative

Updated h6- type of investigation, investigation findings, corrected h6- component code, investigation conclusions.The device was not returned for evaluation.Imagery was provided and the following was observed: in the ct report: tortuosity and calcification present in abdominal aorta.Pictures of events and device: location where delivery system got stuck during insertion through sheath, showing that valve appears to be outside of the sheath.The sheath with delivery system and crimped valve were shown to be in the iliac artery with the crimped valve distal of the triple marker, suggesting that the system was pulled back as a unit although with some difficulty.Additionally, it shows that the delivery system with crimped valve was able to be retrieved back into the sheath lumen.After "vascular surgeons made a long artery cut and finally retrieved the sheath, sheath was torn on almost whole length".A review of edwards lifesciences risk management documentation was performed for this case.The reported events are an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure modes is not required at this time.The complaint for inability to advance through sheath was confirmed by review of returned imagery.Without the return of the complaint device, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, no manufacturing non-conformances were able to be identified.However, an existing technical summary has been documented for root cause analysis on sheath shaft resistance with delivery system complaints.A detailed root cause analysis for similar returned sheath shaft resistance with delivery system complaints has been conducted and summarized in the technical summary.The technical summary provides details of contributing factors for increased resistance during insertion and advancement of the delivery system through the sheath.The following vessel characteristics and procedural factors were identified as the root causes for encountering increased resistance: tortuous patient anatomy can create sub-optimal angles that can lead to non-axial alignment in the advancement of the delivery system.Per the event description, the abdominal aorta had a "twisted orientation" above the bifurcation.Review of the provided imagery reveals tortuosity present.Calcification can reduce the vessel 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.Review of the provided imagery shows calcification present in patient anatomy.Undersized vessels can create a restricted pathway or constrained condition resulting in difficulty during sheath expansion, thereby increased resistance.Right femoral artery is undersized (measuring 5.3 mm, which is less than the minimum lumen diameter of 6.0 mm indicated for 16f sheath); however, the resistance was reported to have been experienced in the abdominal aorta.Vessel lumen measurement was not provided at this location.Steep insertion angle can result in non-coaxial alignment between the delivery system and sheath, which may lead to resistance during advancement.Insertion angle was not provided.The technical summary also outlines the extensive manufacturing mitigations in place to detect a defect or nonconformance associated with an esheath resistance with delivery system.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.As such, available information suggests that patient factors (tortuosity, calcification) may have contributed to the inability to advance through the sheath.The complaint for sheath liner puncture was confirmed by review of returned imagery.Without the return of the complaint device, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, no manufacturing non-conformances were able to be identified.However, an in-depth evaluation regarding complaints with sheath liner tears has been documented in a technical summary.An existing technical summary has been documented for root cause analysis on sheath shaft liner tears with normal liner expansion.In this technical summary, a review of liner tear complaint investigations on returned devices over a two-year period found that patient / procedural factors (e.G.Access vessel tortuosity / calcification or withdrawal of a burst or torn balloon) are likely the contributing factors for sheath shaft liner tears.Per the event description, "during the insertion phase, the system stopped in a twisted orientation, in the abdominal aorta above the bifurcation.It was impossible to move the valve forward and, during the attempt to move it back, it also stopped (the valve never exited the esheath).The initial idea was that maybe the esheath was broken in the place where commander stopped" and "surgeons were able to retrieved part of the esheath, which was completely torn the entire length, and part of the commander with the pusher (valve was still in the esheath." per photos provided, the sheath liner was torn with the delivery system protruding through it.Per evaluation of the provided imagery, calcification and tortuosity were present in the patient's anatomy.Calcification can damage the exposed portion of the sheath liner.Damage along the liner could lead to immediate cutting/tearing or could weaken the liner.A weakened liner can tear during advancement or retrieval of the delivery system.Vessel angulation can create suboptimal angles during delivery system advancement through the sheath.The delivery system or balloon catheter can potentially catch on to liner of the sheath and liner tears upon removal.The technical summary demonstrated that there were no deficiencies in the ifu/training manuals and outlines the extensive manufacturing mitigations in place to detect a defect or nonconformance associated with sheath shaft liner tears.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.It should be noted that these mitigations (from manufacturing and the ifu/training manual), as identified in the technical summary, are still in place.As such, these inspections and testing support that it is unlikely that a manufacturing non-conformance contributed to the complaint.As such, available information suggests that patient factors (tortuosity, calcification) may have contributed to the sheath liner puncture.The complaint for inability to remove sheath was confirmed by review of returned imagery.Without the return of the complaint device, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, no manufacturing non-conformances were able to be identified.However, reviews of the dhr, lot history, and complaint history did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.Furthermore, there was no report of any issue with the sheath during device unpacking or preparation.Per the complaint event, "physicians wanted to remove the esheath and commander as a single unit but it was also impossible, because it was not moving like it was expected.Cardiac surgeons decided to make a surgical cut-down and to try to remove the esheath and commander.It was impossible to retrieve the system from the cut made just below the blocked system, and it was also impossible to retrieve the system from the cut made just above the blocked system.Surgeons were able to retrieved part of the esheath, which was completely torn the entire length, and part of the commander with the pusher (valve was still in the esheath).The decision made was to transfer the patient from the cathlab to the or where vascular surgeons with appropriate backup were able to cut the artery on 10cm length and retrieve the remaining part of the esheath and commander.The system was blocked on calcifications and artery contraction (spasm)." per review of the returned imagery, tortuosity and calcification were present.In addition, the imaging shows the valve outside of the sheath, indicating a torn liner.Per the ifu, "this product is contraindicated for patients with tortuous or calcified vessels that would prevent safe entry of the dilators and sheath" in addition, "remove the sheath entirely without torquing [ensuring the edwards logo is facing upwards]." tortuosity can create sub-optimal angles that can lead to non-axial alignment in the retrieval of the delivery system.Calcification can reduce the vessel diameter and may increase restriction leading to withdrawal difficulty.Calcification can also result in the creation of sub-optimal angles during delivery system removal that may lead to difficulty.As such, available information suggests that patient factors (tortuosity, calcification) may have contributed to the inability to remove the sheath.However, a definitive root cause is unable to be determined at this time.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 ESHEATH INTRODUCER SET
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 15668504
• MDR Text Key: 302365928
• Report Number: 2015691-2022-08815
• 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: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610ES16
• Device Catalogue Number: N/A
• Device Lot Number: 64342539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2022
• 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: 75 YR
• Patient Sex: Female