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EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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| Model Number 9600LDS29A |
| Device Problems
Break (1069); Burst Container or Vessel (1074); Loose or Intermittent Connection (1371); Difficult to Remove (1528); Material Separation (1562); Deformation Due to Compressive Stress (2889); Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)
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| Patient Problems
Death (1802); Perforation (2001); Rupture (2208); Blood Loss (2597); Abdominal Distention (2601)
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| Event Date 04/22/2020 |
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Event Type
Death
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Manufacturer Narrative
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Udi (b)(4).The investigation is underway.This is one of two manufacturer reports being submitted for this case. please reference related manufacturer report no:2015691-2020-11865.
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Event Description
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As reported by a field clinical specialist, this was a valve-in-valve tavr procedure for a 29 mm sapien 3 valve in a pre-existing aortic surgical valve via right transfemoral approach.The commander and valve were introduced into the 16 f esheath on the patient's right femoral.Once the nose cone was at the esheath, the wire was not yet protruding out of the wire port of the commander.The physician had to pull the wire back out of the apex a little in order to get enough purchase for the scrub tech to pinch the wire.The fluoro was positioned as to view the distal end of the esheath and the wire in the apex.As the delivery system was advanced through the esheath it was "dragging the wire with it." at this time it was noted the commander was "bent over on itself." the fluoro was not saved, but the loop was loose enough that there was no way that it could have been within the iliac or aortic arteries.It was then noticed that the flex catheter had externalized through the esheath and arterial system.A coda balloon was advanced to occlude the abdominal aorta.They burst 3 different coda balloons throughout the procedure and code. it was then decided to try with a reliant occlusive balloon which was more stable but not ended up not working.It was decided to remove the devices, and the delivery system was pulled out of the sheath.The balloon catheter had broken and the flex catheter came out without the balloon portion. the balloon catheter was pulled hard enough to strip off the crimped s3 valve from the balloon.They pulled the esheath out and used a new 16 f esheath to plug the arterial hole.At this point, images showed that the crimped s3 valve was in the femoral artery.A vascular surgeon was brought in and it was decided to fix the distal aorta/iliac arteries with endurant stent grafts.During all of this, cpr was being administered.Near the end of the code, 15 units of blood had been given.Once all of the stent grafts were placed, the patient¿s pressures stabilized and cpr was not necessary.It was decided to deploy a new valve via left femoral access. the second 29 mm sapien 3 valve was delivered successfully with good initial hemodynamics and systemic pressures.Physician then initiated a femoral cut down to extract the stripped s3.Within minutes, pressures started to drop again.It was suspected that the endoluminal grafts had not seal the rupture completely and was probably leaking.The abdomen was distended and there was concern of compartment syndrome causing issues, but the decision was made to not open the abdomen.Cpr was terminated and the patient expired.Per medical opinion, the wire position played a role since they did not have the initial rail as the commander was advanced with the wire.The complaint device remains under the custody of the hospital.
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Event Description
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As reported by the field clinical specialist (fcs), this was a valve in valve (viv) tavr procedure for a 29 mm s3 valve in a failing surgical valve via right tf approach.Per the fcs report and medical records review, the esheath was placed in the right femoral artery (rfa) with the tip in the abdominal aorta.An amplatz apex wire was placed into the lv, the ds was loaded on the wire.As per routine, the ds was advanced through the sheath while imaging the tip of the each sheath at the same time as imaging the heart with a amplatz apex wire within the lv.¿due to the patient¿s height, even with the tip of the nosecone up against the esheath hemostatic valve, there was no wire to hold at the end of the ds, with the curved tip of the apex wire traveling into the outflow tract.¿ the wire was backed up slightly, still with the tip barely in the lv, until the cv tech was able to grasp the wire at the distal end of the ds.The cv tech was instructed to allow the wire to "float" slightly, rather than creating a taught rail, to allow the lv end of the wire to get deeper into the lv.The valve was advanced through the esheath hemostatic valve and the distal end of the wire was secured to create a rail.As they were advancing the valve through the sheath, they ¿did not meet any resistance¿.However, the tech holding the distal end of the wire informed the team that it felt as though the physician ¿was pulling on the wire.¿ advancement of the ds was immediately halted, and the image intensifier was brought down into the pelvis.It was found that the ds was folded over in a large curve in the pelvis, seemingly outside of the esheath, making a redundant bend in the ds before the valve exited the sheath.Per the op report, ¿obviously, there was no place for the ds and valve to have gone aside from outside of the esheath and out through the wall of the iliac artery.¿ they pulled the wire taut and straightened out the ds.The patient (pt.) immediately lost blood pressure and cpr was started.It was apparent that there was an iliac artery perforation with hemorrhage.The ds was then pulled back out of the esheath.The ds ¿was pulled hard enough to strip off the crimped s3 valve from the balloon¿ remaining in the rfa and the flex catheter came out without the balloon portion.The pt.Was losing a large amount of blood into the pelvis and abdomen and was completely pulseless requiring cpr.A balloon was inserted into the abdominal aorta and inflated.Pressors and transfusion was given and the pt.Was intubated.Vascular surgery was called.A rupture of the right common iliac artery was identified.On review of the ct angiogram, the pt.'s aorta had severe aortoiliac aneurysmal disease with annular calcification all over down to the femoral arteries.An endoluminal graft was emergently placed in the lower abdominal aorta with bifurcating limbs into both iliacs.Once the bleeding was mostly under control and the pt.Was reasonably stable, it was decided to proceed with tavr procedure to improve the pt.¿s prognosis.A 2nd 29mm s3 valve was placed in the surgical valve from the left tf approach over a safari wire (chosen because of its extra length).The s3 valve was deployed in good position with excellent result.Vascular surgery continued with femoral cutdown to remove the sheaths and the s3 valve in the rfa.The pt.Continued with progressive hypotension and the abdomen was quite firm with anemia and severe metabolic acidosis despite aggressive resuscitation and transfusions of 12 units of rbcs.The pt.Became pulseless again and cpr was resumed.After prolonged efforts resuscitation was discontinued and the pt.Expired in the or due to the major bleeding.Per fcs report, the tavr team believes that the torn seam was a failure of the esheath.Per medical opinion, the issues with the wire position played a key role in the procedural complications since they did not have the initial rail they are used to, as they initially had to advance the wire with the ds.
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Manufacturer Narrative
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Additional information received via medical records. correction to the event description per medical records received. additional information: medical history. implant date removed, added in error.The investigation is ongoing.
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Manufacturer Narrative
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The product was not returned for evaluation.Procedural imagery provided by the site showed calcification and tortuosity present in the abdominal aorta and access vessels.The drawing of the patient¿s vessel with devices inserted through shows the location of the delivery system punctured through the sheath creating a loop.The valve and inflation balloon appear to be inside the sheath.A device history records (dhr) review did not reveal any manufacturing related issues that would have contributed to the reported complaint.A review of the lot history revealed no other similar complaints.The commander delivery system complaint history has been reviewed and no confirmed manufacturing non-conformances were identified.The instructions for use (ifu), device preparation and the training manual were reviewed and no deficiencies were identified.It is to be noted if push force is high, consider slightly pulling back the sheath while advancing the thv/delivery system 1-2 cm.If the working length is insufficient, peel away the loader tube and remove while maintaining delivery system and wire position.Withdraw the delivery system and sheath as a single unit completely from the arteriotomy while maintaining guidewire position.Do not force the thv into the sheath.If resistance is felt, the thv may be caught on the sheath tip.Stop, advance thv past the sheath tip and ensure thv is centered on the flex tip.Rotate the delivery system before trying again.During the manufacturing process, the device was visually inspected and tested several times.All 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 complaint for delivery system kinked, bent was confirmed, while the complaints for delivery system valve dislodged from balloon and distal tip/nose tip separated were unable to be confirmed as no relevant procedural imagery/cine was not provided.Due to unavailability of device, engineering was unable to perform any visual, functional, or dimensional analysis.As a result, the presence of a manufacturing non-conformance was unable to be confirmed.Review of dhr and lot history showed no indication a manufacturing non-conformance contributed to the complaint event.A review of manufacturing mitigations supports that the delivery system has proper inspections in place to detect issues related to the complaint event.A review of ifu/training materials revealed no deficiencies.The delivery system push force can vary due to angle of insertion, thv size, vessel diameter, tortuosity and degree of calcification.Provided imagery of patient anatomy showed calcification and tortuosity present in the vessels.Tortuosity and calcification can create challenging pathways for the delivery system to have to travel through and can prevent the sheath from fully expanding, leading to the resistance felt.Complaint description states that, ¿advancement of the ds was immediately halted¿it was found that the delivery system was folded over in a large curve in the pelvis, seemingly outside of the esheath, making a redundant bend in the delivery system before the valve exited the sheath.¿ in addition, ¿as the physician was advancing the commander through the sheath, it stopped ¿riding¿ on the wire and started pulling the wire as he advanced the commander¿.As the wire was allowed to ¿float¿ during delivery system advancement, it is possible that the wire was dragged along with the delivery system during advancement then exited out of the sheath as excessive push force being applied on the delivery system to overcome the resistance.Since the delivery system/valve was stuck in the distal end, continuous pushing movement of delivery system in the proximal end can create a loop as seen in the drawing after delivery system and wire exited out of the sheath which resulted in the reported kink/bend in the delivery system.A definite root cause cannot be determined at this time.However, available information suggests that patient factors (tortuous/calcified anatomy) and procedural factors (improper guidewire handling during delivery system advancement, excessive force and device manipulation to overcome resistance during device insertion) may have contributed to the reported kink, bend and resulted in the iliac artery injury with subsequent death.Per complaint description, ¿the ds was pulled hard enough to strip off the crimped s3 valve from the balloon¿ remaining in the right femoral artery and the flex catheter came out without the balloon portion.It is likely that the device manipulation and the additional force applied while trying to retrieve the delivery system with crimped valve out of the sheath may have led to the dislodging of the valve and separation of the ds distal end.Available information suggests that procedural factors (device manipulation, excessive force, not retrieving all devices as one unit) may have contributed to the complaint events; however, a definite root cause cannot be determined at this time.Due to the unavailability of the device, it cannot be determined if a manufacturing non-conformance contributed to the reported events.The occurrence rates for these events did not exceed the monthly control limit for the applicable trending categories.Since no product non-conformances or ifu/training deficiencies were identified during the evaluation, no product risk assessment, corrective or preventative actions are required.
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Manufacturer Narrative
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Corrected data: f10, h6.Reference capa-20-00141.
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