MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ESHEATH INTRODUCER SET; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY

Model Number 914ESA

Device Problem Material Split, Cut or Torn (4008)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The investigation is in progress, a supplemental report will be submitted.

Event Description

Edwards received notification from a field clinical specialist that a 26mm s3u valve would not advance through the 14fr esheath.  as reported under fluoroscopy, the valve appeared to be coming out the side of the sheath.The decision was made to remove everything as a whole and insert a new 16fr esheath.The device came out smoothly however a 16fr esheath would not advance.The team then dilated the vessel with a 18fr dilator and then inserted a 20fr non-edwards sheath.A new valve/delivery system was inserted, and deployment was achieved with a great result.Through follow up it was learned that the valve was crimped in normal fashion.The difficulty was experienced about halfway through the sheath.The patient was noted to have some tortuosity and calcification.The insertion angle was not steep and there was not any issues with insertion.The vessel was not pre-dilated.The valve was sticking out through the sheath, no damage to the valve reported and everything was still intact as it was when it came out of the body.The root cause for the 16fr sheath not being able to advance was due to the tortuosity at the external iliac.The devices will be returned for evaluation.

Manufacturer Narrative

The device was returned for evaluation, and an engineering evaluation was performed.The 14fr esheath was received along with a 26mm commander delivery system partially inserted through sheath.Loader cap was found over flex shaft of delivery system.Delivery system was returned locked at default position, no flex and fine adjustment used.Assembly inserted through it.The valve was exposed through sheath liner approximately 4 inches from strain relief.A liner tear was observed with length of 3 inches from 4 inches from strain relief.The sheath was partially expanded until approximately 6 inches from strain relief and hdpe damage and stretching at location of liner tear.One liner strand that was split into two was noted at liner tear location approximately 1.25 inches in length.Curvature was observed on sheath relief.Soft tip minor damage and sheath distal tip damage.Imagery provided by the site was reviewed and the following observations were noted: patient 3mensio exhibited a degree of tortuosity and calcification in the access vessel.During the manufacturing process, the device was visually inspected and tested several times.All the inspections are conducted on 100% of units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.All tested sample units for this lot passed pv testing.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.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 sheath shaft liner strand, sheath shaft liner torn, sheath shaft resistance with delivery system and sheath distal tip split were confirmed based on the visual inspection of returned device.Investigation of the device, dhr, lot history, and complaint history revealed no indication that a manufacturing non-conformance contributed to the event.Review of manufacturing mitigations supported that the sheath has proper inspections in place to detect issues related to the reported event.No ifu/training manual deficiencies were identified.For the complaint of sheath shaft resistance with delivery system, as reported, the difficulty was experienced about halfway through the sheath.The patient was noted to have some tortuosity and calcification.The insertion angle was not steep and there wasn't any issues with insertion'.Per the provided 3mensio, the patient's access vessel was calcified and tortuous.Per training manual, push force can vary due to angle of access and insertion, thv size, vessel diameter, tortuosity and degree of calcification'.The presence of calcification, tortuosity could create a challenging pathway during the delivery system insertion through sheath, and it led high push force and high resistance.As such, available information suggests that patient factors (calcification/tortuosity) may have contributed to the complaint event.However, a definitive root cause is unable to be determined at this time.A capa and product risk assessment have been previously initiated to investigate these complaints.For the complaint of sheath shaft liner torn and sheath shaft liner strand, due to the delivery system insertion resistance, it was possible that excessive force was applied to overcome the resistance, and it could lead to valve strut catch within the sheath liner, and resulting in further liner tear and liner strand.As such, available information suggests that patient factors (calcification/tortuosity) and/or procedural factors (valve strut caught on liner/ excessive device manipulation) may have contributed to the resistance.However, a definitive root cause is unable to be determined at this time.Since no manufacturing non-conformances were identified and no ifu/training deficiencies were identified, no corrective or preventative action is required at this time.For the complaint of sheath distal tip split, as reported, 16f sheath would not advance past a certain point within the patient's anatomy'.It was also mentioned that during insertion of the delivery system through sheath, when inspected under fluoroscopy, valve was coming out the side of the sheath.The valve never exited the sheath through the distal tip.Decision was made to remove everything as a whole and insert new 16fr sheath.Per 3mensio patient access vessel had a degree of tortuosity and calcification.It is possible during insertion, excessive manipulation was used to advance the sheath into the patient.The presence of calcification and tortuosity may have caused damage to the sheath tip split.As such, available information suggests that patient factors (calcification/tortuosity) and procedural factors (excessive manipulation during insertion of device) may have contributed to the complaint event.However, a definitive root cause is unable to be determined at this time.Since no manufacturing non-conformances were identified and no ifu/training deficiencies were identified, no corrective or preventative action is required 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.

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11211523
• MDR Text Key: 228173194
• Report Number: 2015691-2021-00221
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2022
• Device Model Number: 914ESA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1