|
As reported by our (b)(6) affiliate, this was a transfemoral procedure with a 23mm sapien 3 valve in the aortic position.During insertion of the delivery system and valve, resistance with the esheath was experienced through the right common iliac and aorta bifurcation was noted.The valve was implanted without complications, resulting in perfect positioning, and no paravalvular leak or center regurgitation were noted.The delivery system (ds) was removed and proceeded to close the access sites a contrast image showed stenosis, possibly caused by a thrombosis in the tight external iliac and in the right femoral.The thrombosis was treated with an angioplasty balloon and the control image showed improvement; however, patient remained unstable and patient was intubated.A new angiography showed a rupture in the aorta artery, which was treated with a covered stent.An additional angiography revealed that the aorta had been treated, but then a dissection was found at the left common iliac artery.A decision was made to place another stent to repair the iliac leak.The placement of the stents in the aorta artery and in the left iliac artery did not resolve the leak.The ¿main leak¿ point was not found.Patient presented with breathing difficulties, where and the ventilator was having difficulty expanding the lungs, due to the abdominal distension caused by the leakage of blood in the abdominal cavity.A decision was made to open the abdomen and remove all the blood retained in the abdominal cavity and treat the ruptures manually.During open surgery, the cava vein was perforated.All ruptures were repaired, and the abdominal opening was closed.The patient remained stable, treated medically and was transferred for post management care, but expired one day post tavr.Per report, the abdominal aortic rupture and the iliac artery thrombosis were caused by the esheath in addition, it was also noted that the events could be due to a patient¿s condition, (porcelain aorta).The death was due to great loss of blood, peripheral issues and procedural complication.Per provided photo, the esheath showed damage at the distal tip.Of note, the perclose device was used with difficulties, but after a second attempt it was possible to access the artery.In addition, the patient already had basal bradycardia and during the surgery this condition worsened, requiring the administration of noradrenaline and adrenaline.The patient¿s native annulus measured and area of 366.6cm2 by ct.The aortic root was moderately-severely calcified.The patient¿s minimum luminal diameter (mld) measured 5.9mm with moderate-severe vessel calcification.The device will not be returned for evaluation.
|
|
The esheath was not returned to edwards for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.A photograph was provided and revealed the sheath distal tip was opened as designed with minor damage, and severe scratches along the sheath shaft.A 3mensio image was provided and confirmed mild tortuosity and moderate to severe calcification in the patient¿s access vessels.During manufacturing, all inspections are conducted on 100% of the units.Per procedure, the sheaths and the sheath tip are visually inspected for defects.During the manufacturing process the esheath final assemblies are 100% visually inspected by both manufacturing and quality for defects per procedure.During product verification testing, the esheaths are tested for seam separation, expansion force, for fragments on the sheath tip and tensile testing.These inspections during the manufacturing process support that it is unlikely a manufacturing non-conformance contributed to the reported complaint event.A device history record (dhr) review was performed and did not reveal any manufacturing related issues that would have contributed to the reported event. a lot history review was performed and no other complaints for the reported event were noted. a review of the complaint history from october 2019 to september 2020 revealed other similar returned complaints. however, no manufacturing non-conformances were identified during the investigations of the similar complaints. available information suggested that patient/procedural factors contributed to the event.The esheath ifu, commander delivery system device preparation training manual and procedural manual were reviewed for guidance/instruction involving the esheath an delivery system usage.The ifu provides contraindications on patients with tortuous or calcified vessels that would prevent safe entry for the dilators and esheath.In addition, the procedural manual provides guidance on vascular complications management.Successful management of vascular complications depends on being prepared, first priority should be controlling bleeding through endovascular techniques with an iliac occlusion balloon or reinsert dilator but do not reinsert sheath if removed. repair can be performed surgically or with endovascular techniques: surgical instruments should be ready in every case and consider vascular surgery.A review of ifu/training materials revealed no deficiencies were identified.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 sheath distal tip damaged was unable to be confirmed based on imagery provided from the site.The complaint for insertion difficulty in patient was confirmed based on severe scratches, which observed on sheath shaft.Without the device being returned for evaluation, additional visual, dimensional, and/or functional testing could not be performed, and therefore a presence of manufacturing non-conformance could not be determined.A review of lot history, complaint history, dhr, and manufacturing mitigations did not provide any indication that a manufacturing non-conformance of the esheath was the source of the complaint.A review of the ifu and training manuals revealed no deficiencies.As reported ¿esheath faced some resistance when passing through the right common iliac and aorta bifurcation¿, and ¿it could be due to a patient¿s condition, possibly porcelain aorta¿.Review of the case description and imagery, patient had mild tortuous and moderate to severe calcified access vessel.Additionally, the severe scratches were observed on sheath shaft, which was indicative the presence of severe calcification.The presence of calcification and tortuosity in access vessels could create a challenging pathway during the sheath insertion into the patient, which could lead to high resistance and push force.According to the procedural training manual, ¿push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification.Per procedural training manual, ¿an open tip and seam are to be expected.¿ the sheath distal tip was opened as designed.Damage of sheath distal tip would likely occur due to interaction with calcified access vessels.So, if excessive force was applied to overcome the resistance for sheath insertion, it could lead to sheath distal tip damaged.Per the instructions for use (ifu) cardiovascular injury, such as perforation dissection of vessels, ventricle, myocardium or valvular structures, is a known potential complication associated with the tavr procedure.According to the thv training manuals, risk factors for aortic dissection, hematoma or annular rupture during the tavr procedure include significant thv over sizing, severely obliterated sinuses of valsalva, porcelain aorta and/or presence of bulky calcification and narrow calcified stj. in addition, advanced age, female gender, small body weight, and steroid dependency can also be contributing factors.The sapien 3 valve relies on native valve calcium to securely anchor to the annulus.Despite this beneficial aspect of calcium, bulky calcium can increase the risk of calcific nodule displacement into the vasculature, which can lead to vascular injury.At times the extent and distribution of calcium can impair ease of delivery of the valve, correct positioning of the valve, deployment of the valve and procedural success.Per the instructions for use (ifu), potential risks associated with the overall tavr procedure, including potential access complications associated with standard cardiac catheterization procedure, balloon valvuloplasty, and the use of angiography include thrombus formation, plaque dislodgement, and embolization that may result in myocardial infarction, stroke, distal peripheral occlusion and/or death.Included under contraindications for the transfemoral procedure are patients with significant aortic disease, including arch atheroma (especially if thick [> 5 mm], protruding or ulcerated) or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta.Calcification and atheromas (cellular debris, inflammatory cells, and cholesterol) can accumulate along the walls of the vasculature and within cardiac structures and can vary in size.There may be cases where a patient has a protruding atheroma or calcified plaque prior to the procedure.It is also possible for one of the interventional devices used during the thv procedure to disrupt the material, resulting in mobile debris.In this case, available information suggests that patient factors (calcification) and/or procedural factors (excessive device manipulation) may have contributed to the events.However, a conclusive root cause is unable to be determined 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. no ifu/training deficiencies were identified.Therefore, neither a product risk assessment or corrective or preventative action is required.
|
