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

Model Number 9610ES14

Device Problems Peeled/Delaminated (1454); Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)

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

Event Date 08/13/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted upon completion.

Event Description

Edwards received notification from our affiliate in (b)(6).As reported, a 26mm sapien 3 ultra case in aortic position by transfemoral approach.During the procedure, crimping was done without any problems, however, during the insertion of the valve through the 14fr esheath, the system could not be pushed through the esheath.The esheath was removed with the ds as a whole unit, and a 16fr esheath was inserted.The 26mm sapien 3 valve was implanted successfully.The patient outcome was good.As per medical opinion, the root cause of the event may have been that in spite of the diameter of the iliofemoral tree ( femoral 6.4, external iliac 6.9) which is still safe for a 14fr sheath, the manner of calcification of the iliofemoral access did not allow the sheath to expand during the valve insertion.This lead to friction between the valve and the sheath which totally distorted the valve.At pre-decontamination evaluation, the following was observed on the sheath and valve: 3 kinks observed on sheath, 2 liner strands observed, sheath distal tip split, slight bent struts observed on crimped valve.

Manufacturer Narrative

The device was returned for evaluation and an engineering evaluation was performed.The esheath was visually inspected upon return and the following was observed: two kinks observed on sheath shaft (first kink 0.75 inches from distal end of strain relief, second kink 3.25 inches from distal end of strain relief).Two liner strands were observed (first strand 3.25 inches from distal tip and approximately 3.5 inches in length, and second strand attached to the first strand and approximately 1.75 inches in length).Sheath distal tip was opened with hdpe split, and minor soft tip damaged.Heavy scratches seen along sheath shaft.Minor kink on strain relief, approximately 0.25 inches from sheath hub.Liner tear observed, starting from distal end of strain relief and approximately 8.5 inches in length.The device history record (dhr) was reviewed and the work orders did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.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 inability to advance through sheath, sheath distal tip split, sheath kinked/bent, sheath liner torn, and sheath liner strand were confirmed through evaluation of the returned device.However, no manufacturing nonconformances were identified during the evaluation.Reviews of the dhr, lot history, and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.As reported, 'while advancing the commander delivery system with crimped valve through the 14fr esheath, resistance was encountered, and the valve got stuck.Therefore, all devices were removed together as a unit and new devices were prepared'.Per case notes, calcification was noted within the patients access vessels.Additionally, evaluation of the returned device revealed the presence of a shaft kink, which can be indicative the sheath's interaction with vessel tortuosity.The procedural training manual states, 'push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification.' while vessel tortuosity can create a challenging pathway for delivery system insertion, calcification can reduce the vessel diameter preventing sheath from proper expansion, which both may lead to resistance.In such condition, attempts to manipulate the device to overcome the resistance could result in the valve interacted with the sheath and damaged the sheath shaft including kinks, liner tear, and liner strands.As such, available information suggests that patient factors (calcification/tortuosity) and procedural factors (excessive manipulation, valve strut caught on liner) may have contributed to the reported events.A product risk assessment was previously performed per management discretion to assess the risks associated with high push force of the sapien 3 ultra valve with the commander delivery system and esheath configuration.In addition, a capa was previously initiated to capture further investigation and any possible corrective or preventative action activities.For the complaint of sheath distal tip split, per evaluation of the provided device, the sheath distal tip was opened with hdpe split and minor soft tip damaged.Per case notes, calcification was noted by the site to have contributed to the noted resistance.The scratches seen along the shaft indicated that calcium nodules within the vessel likely interacted with the sheath during device insertion/advancement, causing the distal tip to split and the sheath shaft to become damage.Available information suggests that patient factors (calcification) may have contributed to the reported event.However, a definitive root cause was unable to be determined at this time.No ifu/labeling/training manual inadequacies or manufacturing nonconformance were identified.Therefore, no corrective or preventative actions, nor product risk assessment (pra) 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.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2021-05330.

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• 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: 12460667
• MDR Text Key: 271054821
• Report Number: 2015691-2021-05153
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103191219
• UDI-Public: (01)00690103191219(17)230209(10)63640566
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2023
• Device Model Number: 9610ES14
• Device Catalogue Number: N/A
• Device Lot Number: 63640566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2021
• 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 Sex: Male