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

Model Number 916ESPA

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Activation Failure (3270)

Patient Problems Unspecified Vascular Problem (4441); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2022

Event Type  Injury  

Event Description

As reported by a field clinical specialist (fcs), prior to the start of case, patient's tortuosity was discussed.During the procedure of a 29 mm sapien 3 valve in the aortic position via transfemoral approach, the team's 1st attempt at deploying the 29 mm valve was over a safari extra stiff wire using a 16 french esheath plus.The sheath was placed over an amplatz super stiff wire.The 1st valve and delivery system entered the esheath and was advanced.The valve never exited the sheath into the descending aorta due to tortuosity.While attempting to advance, the area between the pusher of the delivery system and the valve kinked.The team attempted to try to reverse and change angle but they were unable to make forward movement at about the common iliac into the aorta.The decision was then made to try to remove the sheath and delivery system as a unit.They were able to bring the valve and sheath back to about the external iliac but then they got stuck.On fluoro you could see the whole vessel moving when they tried to advance to retract.The team then performed a cutdown with the vascular surgeon.Even after exposing the vessel the team had trouble removing the system and sheath.The vascular team then made a second incision and cutdown on abdomen to try and secure and free the sheath from the right external iliac.Eventually the surgeon was able to expose the distal end of the sheath through the abdominal incision, push the delivery system with valve crimped on it.The team then cut through the pusher of the delivery system and pulled off the distal end with the valve attached.They were then able to remove the remaining delivery system and sheath from the vessel.Next the vascular surgeon sewed a 10 mm conduit to the common iliac artery which we then placed a 22 fr gore dryseal through and deployed a 29 mm sapien 3 valve.The patient did receive one unit of blood during the procedure due to blood loss.Per engineering evaluation, sheath does not expand was noted.Proximal piece seam was expanded until 2.0 in beyond strain relief, remaining length was unexpanded, with liner stretching observed.

Manufacturer Narrative

Engineering evaluation of the returned delivery system indicated that the valve and delivery system never fully advanced through the sheath as evident by the unopened sheath tip.The investigation did not confirm any device defects or manufacturing non-conformance's on the delivery system that may have contributed to the reported event.The delivery system and valve were within the sheath when withdrawal difficulties were noted and no non-conformance were discovered during the evaluation of the delivery system.As such this event is now being reported against the esheath (please reference related manufacture number: 2015691-2022-06397).The esheath plus was returned to edwards lifesciences for evaluation.A device history record review (dhr) and lot history review were performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.The following observations were made based on evaluation of the complaint device.The seam was expanded till 2" from strain relief.The remaining length was unexpanded.The distal 2" was expanded and remaining proximal length was unexpanded.The distal end of shaft was compressed, and tip was unopened.Liner stretching observed on liner of both shaft pieces.Additionally, delivery system flex tip gouges was observed.The liner was cut by site 2.25" from distal tip.The instructions were reviewed instruction for use (ifu) for esheath+ introducer set, commander delivery system ifu, device preparation training manual, procedural training manual and no ifu/training deficiencies were identified.The complaints were confirmed based on procedural imagery and evaluation of the complaint device.No manufacturing non-conformance's were identified through evaluation of the returned device.A review of dhr, lot history, complaint history, and manufacturing mitigation's supported that a manufacturing non-conformance likely did not contribute to the reported events.A review of ifu/training materials revealed no deficiencies.In addition, an in-depth evaluation regarding complaints for esheath liner stretching as the seam not expanding during delivery system advancement has been documented in technical summary.The condition of the returned device revealed evidence of liner stretching.An existing technical summary has been documented to capture the investigation for esheath liner stretching when the hdpe outer layer adheres to the etched ptfe liner preventing the seam from opening.Technical summary is applicable to esheath+ introducer set as there are no significant changes related to the sheath shaft.This includes material composition, manufacturing process, inspection, and testing.The only update is related to the strain relief material at the proximal end of the sheath shaft.This was modified to improve manufacturability at the component level for improvements relating to extrusion and handling and does not affect system advancement through the sheath.See technical summary for a comprehensive comparison between esheath and esheath+.Device performance, including advancement forces were verified to meet specification per design verification reports.Per technical summary a design verification and clinical assessments have been documented that demonstrate how seam stretching will still allow the sheath to meet clinical intent.The testing showed that there was no impact on the form, fit, or function of the esheath when the seam stretches instead of opens and that liner stretching is cosmetic and poses negligible risk to the patient.Additionally, per the manufacturing acceptance criteria b, a liner that is stretching or does not open in the proximal and middle region of the sheath shaft, is acceptable as long as the distal 2" segment of the sheath is open after full expansion of the device (and calculated push force of tested units meet specification), which was shown on the returned device.Therefore, this failure mode occurs when the hdpe outer layer adheres to the etched ptfe liner resulting in the seam to stretch, but has no impact to the form, fit, or function of the esheath.This remains a cosmetic issue, posing negligible risk to the patient.Per the complaint description, "the 1st valve and delivery system entered the esheath and was advanced.The valve never exited the sheath into the descending aorta due to tortuosity.While attempting to advance, the area between the pusher of the delivery system and the valve kinked.The team attempted to try to reverse and change angle but they were unable to make forward movement at about the common iliac into the aorta.The decision was then made to try to remove the sheath and delivery system as a unit".As noted in the case notes and 3mensio imagery, the patient had access vessel tortuosity, which can lead to non-coaxial alignment between the devices during delivery system insertion and advancement.Similarly, tortuosity can create a challenging pathway for device withdrawal due to the suboptimal angles.As such, available information suggests that patient factors (tortuosity) may have contributed to the complaint events.Since no product non-conformance or ifu/training deficiencies were identified during evaluation, a product risk assessment (pra) escalation or a corrective preventative action (capa) is not required.

Manufacturer Narrative

A supplemental mdr is being submitted to provide better clarification on h10 and correct codes entered in h6.H6: remove impact code, 2199 - no health consequences or impact.H6: remove clinical code, 4582 - no clinical signs, symptoms or conditions.In this case, the vascular injury was initially reported under manufacture number: 201569-2022-06397, however per engineering evaluation of the returned delivery system indicated that the valve and delivery system never fully advanced through the sheath as evident by the unopened sheath tip.The investigation did not confirm any device defects or manufacturing non-conformances on the delivery system that may have contributed to the reported event.As such this event is now being reported against the esheath.Per the instructions for use (ifu), cardiovascular injuries such as perforation or dissection of vessels, ventricle, myocardial or valvular structures are known potential risks or adverse events associated with the overall thv procedure and may require intervention.The esheath plus was returned to edwards lifesciences for evaluation.A device history record review (dhr) and lot history review were performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.The following observations were made based on evaluation of the complaint device.The seam was expanded till 2" from strain relief.The remaining length was unexpanded.The distal 2" was expanded and remaining proximal length was unexpanded.The distal end of shaft was compressed, and tip was unopened.Liner stretching observed on liner of both shaft pieces.Additionally, delivery system flex tip gouges was observed.The liner was cut by site 2.25" from distal tip.The instructions were reviewed instruction for use (ifu) for esheath+ introducer set, commander delivery system ifu, device preparation training manual, procedural training manual and no ifu/training deficiencies were identified.A review of the risk management documentation was performed, and the reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.The complaints were confirmed based on procedural imagery and evaluation of the complaint device.No manufacturing non-conformances were identified through evaluation of the returned device.A review of dhr, lot history, complaint history, and manufacturing mitigations supported that a manufacturing non-conformance likely did not contribute to the reported events.A review of ifu/training materials revealed no deficiencies.In addition, an in-depth evaluation regarding complaints for esheath liner stretching as the seam not expanding during delivery system advancement has been documented in technical summary.The condition of the returned device revealed evidence of liner stretching.An existing technical summary has been documented to capture the investigation for esheath liner stretching when the hdpe outer layer adheres to the etched ptfe liner preventing the seam from opening.Technical summary is applicable to esheath+ introducer set as there are no significant changes related to the sheath shaft.This includes material composition, manufacturing process, inspection, and testing.The only update is related to the strain relief material at the proximal end of the sheath shaft.This was modified to improve manufacturability at the component level for improvements relating to extrusion and handling and does not affect system advancement through the sheath.Device performance, including advancement forces were verified to meet specification per design verification reports.Per technical summary, a design verification and clinical assessments have been documented that demonstrate how seam stretching will still allow the sheath to meet clinical intent.The testing showed that there was no impact on the form, fit, or function of the esheath when the seam stretches instead of opens and that liner stretching is cosmetic and poses negligible risk to the patient.Additionally, per the manufacturing acceptance criteria b, a liner that is stretching or does not open in the proximal and middle region of the sheath shaft, is acceptable as long as the distal 2" segment of the sheath is open after full expansion of the device (and calculated push force of tested units meet specification), which was shown on the returned device.Therefore, this failure mode occurs when the hdpe outer layer adheres to the etched ptfe liner resulting in the seam to stretch, but has no impact to the form, fit, or function of the esheath.This remains a cosmetic issue, posing negligible risk to the patient.Per the complaint description, "the 1st valve and delivery system entered the esheath and was advanced.The valve never exited the sheath into the descending aorta due to tortuosity.While attempting to advance, the area between the pusher of the delivery system and the valve kinked.The team attempted to try to reverse and change angle but they were unable to make forward movement at about the common iliac into the aorta.The decision was then made to try to remove the sheath and delivery system as a unit".As noted in the case notes and 3mensio imagery, the patient had access vessel tortuosity, which can lead to non-coaxial alignment between the devices during delivery system insertion and advancement.Similarly, tortuosity can create a challenging pathway for device withdrawal due to the suboptimal angles.As such, available information suggests that patient factors (tortuosity) may have contributed to the complaint events.Since no product non-conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment (pra) escalation or a corrective preventative action (capa) is not required.

• Brand Name: ESHEATH PLUS INTRODUCER SHEATH
• 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: 15472999
• MDR Text Key: 300563619
• Report Number: 2015691-2022-08039
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2024
• Device Model Number: 916ESPA
• Device Lot Number: 64264338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2022
• 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 Sex: Male