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

Model Number 9610ES16

Device Problems Difficult to Insert (1316); Peeled/Delaminated (1454); Material Integrity Problem (2978); Physical Resistance/Sticking (4012)

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

Event Date 05/11/2022

Event Type  malfunction  

Event Description

As reported by an edwards croatia affiliate, during a transfemoral tavr procedure with a 29mm sapien 3 valve, resistance was felt in the right external and common iliac during insertion of the delivery system and valve.The vessel was calcified and the insertion angle was mild and normal.During valve deployment, the balloon ruptured at the end of inflation.The valve was fully deployed with good results.During retrieval of the devices, the introducer and delivery system were pulled out together, but the nosecone and the distal part of the balloon were 'stacked' in the right iliac artery.While maneuvering to get the delivery system out of the right iliac, the tip of the delivery system was detached and was pulled out with a snare.There were no other issues and the procedure was successfully done.The patient recovered well.As per preliminary evaluation of the esheath, the shaft was damaged and the liner was torn and stranded.

Manufacturer Narrative

Investigation is still ongoing.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2022-06069.

Manufacturer Narrative

A device history record (dhr) review did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to the reported event were identified.The esheath was visually inspected upon return and the following was observed: the sheath was fully expanded, as designed, the sheath distal tip was opened, as designed, the first liner tear noted with length of approximately 76mm starting from the distal tip, the second liner tear noted located 20 mm from distal tip with length of approximately 30 mm, the liner strand observed near liner tear, two kinks noted along distal end of shaft, damage/tear noted near distal tip, and the liner was partially delaminated at distal tip, but c-marker remained attached.Due to the condition of the returned device (sheath expanded, tip opened, liner torn), no applicable functional testing was able to be performed.However, dimensional testing was performed.The liner thickness was measured along the length of the first liner tear.Due to the nature of the tear, measurements were only able to be performed on one side.All measurements met specification.The 3mensio imagery report and procedural imagery was provided by the facility, and the following was observed: procedural cine imagery was determined to not be relevant as it only shows the expanded valve within the patient, and 3mensio imagery shows presence of calcification and tortuosity.The instructions for use/training manuals were reviewed for guidance/instruction involving the esheath usage.Based on the review of the ifu/training manuals, no deficiencies were identified.A review of edwards lifesciences risk management documentation was performed for this case.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 for difficulty advancing through esheath, esheath liner torn, esheath liner strand, and esheath damaged were confirmed through evaluation of the returned device.However, the complaint for difficulty introducing esheath was unable to be confirmed.Per the complaint description, 'resistance was felt while advancing the commander delivery system with crimped valve through the esheath'.A detailed root cause analysis for similar returned sheath shaft resistance with delivery system complaints has been conducted and summarized in a technical summary written by edwards lifesciences.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 vessels can create sub-optimal angles that can lead to non-axial alignment in the advancement of the delivery system.Per imaging evaluation, the patient's access vessel had presence of tortuosity.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.Per imaging evaluation, the patient's access vessel had presence of calcification.Undersized vessels can create a restricted pathway or constrained condition resulting in difficulty during sheath expansion, thereby increased resistance.Per imaging evaluation, the patient's access vessel was sufficiently sized.Steep insertion angle can result in non-coaxial alignment between the delivery system and sheath, which may lead to resistance during advancement.The insertion angle was reported to be 'mild and normal'.Per evaluation of the returned device, the sheath liner was torn.In-depth evaluation regarding complaints for sheath shaft liner torn has been documented in the technical summary.The 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.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.Incomplete deflation of the compatible balloon device prior to removal from the sheath can damage the liner.A balloon burst or tear could also make it difficult to deflate the balloon and would alter the balloon profile during removal.The force required to withdraw the balloon could then lead to tearing or weakening of the sheath liner.Per the complaint description, 'while inserting the esheath into the right external and common iliac, resistance was felt'.Calcification and tortuosity were noted in the patient's access vessel and can create a challenging pathway for sheath insertion/advancement.Calcification can lead to friction, while tortuosity can subject the sheath to suboptimal angles during advancement.As such, available information suggests that patient factors (calcification, tortuosity) may have contributed to the complaint event.Per evaluation of returned device, the sheath was damaged near the distal tip and one liner strand was observed along the tear.Per imaging evaluation, the patient's access vessel had presence of calcification.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.In addition, per the complaint description, the delivery system balloon was ruptured.A balloon burst or tear could also make it difficult to deflate the balloon and would alter the balloon profile during removal.The force required to withdraw the balloon could then lead to tearing of the sheath liner, leading to strands.Similarly, these factors may lead to the observed shaft damage, especially if compounded with excessive device manipulation.As such, available information suggests that procedural factors (valve caught on liner, excessive manipulation) may have contributed to the complaint 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 corrective or preventative actions are required.

• Brand Name: EDWARDS ESHEATH INTRODUCER
• 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: 14626609
• MDR Text Key: 301242018
• Report Number: 2015691-2022-06096
• 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,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

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 Expiration Date: 01/24/2024
• Device Model Number: 9610ES16
• Device Lot Number: 64183848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/07/2022
• Supplement Dates Manufacturer Received: 08/09/2022
• Supplement Dates FDA Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2022
• 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 Age: 84 YR
• Patient Sex: Male