MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number 9610TF29

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

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

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

The device return and investigation are pending, a supplemental report will be submitted.

Event Description

Edwards received notification from our affiliate in (b)(6) of a 29mm sapien 3 case in pulmonic position by transfemoral approach.As reported, the first commander delivery system was prepared following ifu and the 29 mm sapien 3 valve was crimped as usual and inserted into the patient.The system went all the way through a long dry seal 24f introducer without complications.The issue started when the balloon was brought into the crimped valve and a lot of resistance at the end of the positioning was felt.No tools were used to remove the balloon cover.When the scope image was checked, the tip of the balloon appeared to be wrinkled.Negative pressure was pulled on the balloon inflator, in order to try to improve the appearance of the commander, but the patient's blood entered the inflator (clear sign of balloon rupture).The balloon was still empty and it was just prepared as usual with contrast solution to remove the air.The balloon was not inflated when the leak was found.The difficulty started by the end of the gross alignment and got worse on the fine alignment.The entire delivery system and dry seal introducer were removed from the patient as a single unit, in order to check what happened and it was tried not to damage the valve.It was tried to inflate the balloon out of the patient, but all the injected content sneezed and the balloon rupture was confirmed.Another kit was opened and a second commander system was prepared, with a new sapien 3 valve.Once again, the system was prepared as usual.For this second attempt, the positioning was done outside the patient, following the steps presented in a published study of treatment of the pulmonary valve with sapien 3.The second delivery system went all the way uneventfully and the 29mm sapien 3 was positioned correctly, resulting in an excellent outcome.Optimal positioning, without leaks.On post operative day 7, the patient was discharged.The patient outcome was good.As per medical opinion, the root cause of the event was that the valve alignment was made within the patient.When the valve alignment was done outside of the patient, there was no problem with the insertion of the system or positioning of the valve.

Manufacturer Narrative

The device was not returned for evaluation.Therefore, a no product return engineering evaluation was performed.Review of procedural videos/imagery/photographs were performed and the following was observed: device post procedure showed the delivery system was cut in order to be removed from the patient.Distal and proximal flex shaft, distal portion of delivery system and crimped valve pictured separately.Crimp balloon torn proximal to inflation balloon/crimp balloon (i/c) bond and balloon wings appear flared.Severe compression observed on the distal flex shaft.Procedural cine showed compression of the flex shaft observed during valve alignment.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.A lot history review was performed and revealed no other complaints relating to this 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 valve alignment difficulty and balloon torn were confirmed by the provided imagery.Due to unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing nonconformance was not identified.A review of the dhr, lot history, and complaint history did not provide any indication that a manufacturing non conformance would have contributed to the complaints.A review of ifu/training materials revealed no deficiencies.Potential root causes for separation of the inflation balloon to crimp balloon bond have been identified and documented in a product risk assessment (pra).As identified in the pra, high forces on the system during valve alignment may result in crimp balloon tearing prior to thv deployment.Potential sources of high forces, which will impact difficulty with aligning the valve, include performing valve alignment in tortuous vasculature.Per the cer, the patient had mild tortuosity.Performing valve alignment in a non straight section of the vasculature can cause the valve to dive into the lumen of the flex tip where part of the crimped valve slides into the flex tip lumen.If the thv is unseated (non coaxial placement of valve in relation to the flex tip) during alignment, it can result in higher than usual valve alignment forces (as evidenced by the flex shaft compression) and can potentially weaken the crimp balloon and cause tension to the system.Per the training manual, if excessive tension is experienced during valve alignment, repositioning the delivery system to a different straight section of the vasculature and relieving compression (or tension) in the system will be necessary.As reported, when the scope image was checked, the tip of the balloon appeared to be wrinkled.Due to the balloon tear, the balloon profile may have been altered during valve alignment.A definite root cause was unable to be determined at this time.However, available information suggests patient (tortuosity) and procedural factors (valve alignment performed in a non straight section/high alignment forces) contributed to the reported event.For the complaint of valve alignment difficulty, no labeling, training, or ifu deficiencies were identified.Therefore, no corrective and preventative action nor pra is required at this time.The complaint of balloon torn was confirmed.However, no manufacturing nonconformances were identified during evaluation.No labeling, training, or ifu deficiencies were identified.Therefore, no corrective and preventative action nor pra is required at this time.However, per management discretion, the balloon torn issue and it associated risks have previously been assessed and documented in a pra.A capa was previously initiated to address this failure mode.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.

Manufacturer Narrative

An administrative review of 3500a forms posted on the maude database showed this manufacturer report was submitted with the incorrect pma number.A correction to fields g4 is being submitted in this supplemental report.

Manufacturer Narrative

The device was returned for evaluation and an engineering evaluation was performed.The 29mm commander delivery system was returned, locked at the warning marker with half flex and no fine adjust in use.The delivery system was inserted through the full loader assembly.The device was cut into multiple pieces (proximal delivery system, distal flex shaft, portion of guidewire lumen, balloon.) visual inspection of the returned device was performed and the following was observed: compression observed 1.25'' from flex tip.No visual abnormalities on crimp or inflation balloon.I/c bond appeared intact.Valve alignment was able to be performed with the proximal delivery system.Gross alignment was performed with no issues.The balloon lock was able to lock and unlock.Full fine adjust was able to be performed.The balloon was unable to be inflated due to the returned condition (delivery system cut into fragments).The complaint for fine adjust valve alignment difficulty was confirmed.However, the complaint for of delivery system leakage was unable to be confirmed.However, a manufacturing nonconformance was not identified.A review of the dhr, lot history, manufacturing mitigations and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaints.A review of ifu/training materials revealed no deficiencies.Per the cer, the patient had mild tortuosity.Performing valve alignment in a non-straight section of the vasculature can cause the valve to 'dive' into the lumen of the flex tip where part of the crimped valve slides into the flex tip lumen.If the thv is unseated (non-coaxial placement of valve in relation to the flex tip) during alignment, it can result in higher than usual valve alignment forces (as evidenced by the flex shaft compression) and can potentially weaken the crimp balloon and cause tension to the system.Per the training manual, ''if excessive tension is experienced during valve alignment, repositioning the delivery system to a different straight section of the vasculature and relieving compression (or tension) in the system will be necessary.'' as the delivery systems are 100% tested for leakage, and as this issue was undetected during preparation, it is likely that damage to the delivery system occurred during the procedure.Due to the condition of the returned device (cut in multiple pieces and unable to inflate), the exact location and nature of the leak is unknown.However, possible sources of delivery system leaks could be a tear/pinhole on the balloon.Per the case notes provided, the patient did have mild calcification and tortuosity.It is possible the valve was unseated during valve alignment, which can result in interaction with the valve and the crimp balloon, which may have punctured the balloon and resulted in the observed pinholes.Additionally, it is possible some manipulation used during tracking of the system through calcified and tortuous anatomy could have inadvertently damaged the balloon and lead to the reported leakage.A definite root cause was unable to be determined at this time.However, available information suggests patient (calcification/tortuosity) and procedural factors (valve alignment performed in a non-straight section) contributed to the reported event.No labeling, training, or ifu deficiencies were identified.Therefore, no corrective and preventative action nor 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.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: PULMONARY 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: 11867781
• MDR Text Key: 252333601
• Report Number: 2015691-2021-03109
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00690103193008
• UDI-Public: (01)00690103193008(17)221022(10)63468183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200015
• 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,Followup,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2022
• Device Model Number: 9610TF29
• Device Lot Number: 63468183
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2020
• 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: 61 YR
• Patient Sex: Male