EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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Model Number 9600LDS26J |
Device Problems
Burst Container or Vessel (1074); Perivalvular Leak (1457); Difficult to Remove (1528); Material Rupture (1546); Mechanical Jam (2983)
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Patient Problems
Calcium Deposits/Calcification (1758); No Known Impact Or Consequence To Patient (2692)
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Event Date 04/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Per the instructions for use (ifu), balloon rupture is a potential risk of the tavr procedure.The device was discarded at the hospital and will not be returned for evaluation.Transcatheter delivery balloon burst complaints have been previously investigated by edwards and documented in a clinical technical summary written by edwards lifesciences.A detailed root cause analysis revealed that it is very unlikely that a product defect contributes to this type of event.There are extensive manufacturing inspections in place to prevent this type of malfunction (visual and dimensional inspections, leak testing, and functional balloon burst testing performed to every manufactured lot).The thv delivery system balloons are subject to increased risk of burst due to contact with a highly calcified annulus.Analysis revealed that these types of ruptures are typically caused by puncture from calcium on the native aortic valve when the inflated delivery system balloon comes in contact with the native annular calcification at full inflation/deployment.In this case, with the information provided, the most likely cause of the balloon burst and subsequent withdrawal difficulties was the calcification at the st junction.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required at this time.
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Event Description
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As reported by the edwards (b)(6) affiliate, during a tf tavr case there were no problems with insertion of the esheath, delivery system, or valve alignment.Balloon valvuloplasty was omitted and the valve was directly deployed.The balloon of the delivery system ruptured during deployment while injecting the contrast solution.Lots of backflow of blood was seen in the inflation device.Echo did not show any abnormalities.However, a decision was made to perform post-dilation as cine image indicated a bit less expansion of the valve and more than mild paravalvular leak (pvl).When removing the delivery system, strong resistance was felt indicating the torn balloon got stuck at the sheath tip.The devices were retracted together as a set.Post-dilation was done with an 18fr dryseal sheath and a 25mm edwards balloon.This achieved full expansion of the valve and the pvl disappeared.Angiography did not show any injuries in the access vessel and the procedure was completed.The physician mentioned that the balloon rupture seemed to be due to calcification in the st junction.The aortic annulus area measured 500mm2 and moderate calcification was observed in the st junction.The device was discarded at the hospital and not returned for evaluation.
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Manufacturer Narrative
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No procedural videos, imagery, or photographs were provided for the evaluation.A dhr review was performed on work orders related to the manufacturing of the devices and components that could potentially contribute to the events.None of the work orders above revealed any issues that may have contributed to the reported event.During manufacturing of the commander delivery system, the delivery system and components are inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformance contributed to the reported events.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.No evidence of a product non-conformance or labeling/ifu inadequacies were identified in the evaluation.The events were unable to be confirmed due to no returned device or applicable imagery of the complaint device.Per the description summary, ¿the balloon of delivery system ruptured on injecting all contrast solution.When removing the delivery system, strong resistance was felt indicating the torn balloon got stuck at the sheath tip¿.The patient was noted to have moderate degree of calcium was observed in sj junction.Based on this information, it is likely that the root cause of the balloon burst and delivery system withdrawal difficulty- through sheath is related to those detailed in a technical summary written by edwards lifesciences.A detailed root cause analysis for similar returned complaints has been summarized in the technical summary.The technical summary provides a rationale as to why it is unlikely that a product defect or manufacturing non-conformance contributed to this type of event; and it details why balloons are subject to increased risk of burst in a calcified annulus.This patient had moderate degree of calcium in sj junction.The presence of calcification can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested for rated burst pressures well above their inflation pressure, calcified nodules can compromise the structure of the balloon wall via following mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.The technical summary also outlines the extensive manufacturing mitigations in place to prevent this type of malfunction (visual and dimensional inspections, leak testing, and functional balloon burst testing that occurs with every manufactured lot).Additionally, the technical summary applies to cases related to burst balloons that resulted in difficulties withdrawing the delivery system.As such, the reported events discussed in this complaint are likely related to the details outlined in the technical summary.It is possible that the balloon burst resulted in the withdrawal difficulties noted.As a burst balloon has an altered profile, which may have led to the withdrawal difficulty through sheath.Available information therefore suggests that patient factors (calcification) and procedural factors (withdrawal of balloon burst) likely contributed to the complaint events.The complaint occurrence rate did not exceed the (b)(6) 2020 control limit for the applicable trend categories.Since no edwards defect was identified in the evaluation, no corrective or preventative action is required.
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Manufacturer Narrative
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Corrected data: f10, h6.Reference capa-20-00141.
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Search Alerts/Recalls
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