BOSTON SCIENTIFIC CORPORATION NC QUANTUM APEX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 6532 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Chest Pain (1776); Death (1802); Thrombosis (2100); Cardiogenic Shock (2262); Respiratory Failure (2484)
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Event Date 09/04/2018 |
Event Type
Death
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Event Description
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It was reported that the patient died.Vascular access was obtained via the right radial and femoral artery.The 90% stenosed, 22x2.5mm, concentric and the de novo target lesion was located in the mildly calcified left anterior descending (lad) artery.A 3.5 (6f) non-bsc guide catheter was advanced in the ostium of the left coronary artery and a non-bsc guide wire was used to cross the significant stenosis of the proximal lad segment.Pre-dilation was performed with a 2.0 x 20mm non-bsc balloon catheter, leaving 30% residual stenosis in the lesion.A 2.50x24mm promus element plus drug-eluting stent was advanced but failed to cross the distal part of the stenosis.The stent was pulled back into the guide catheter with intention to perform a pre-dilatation with a larger balloon size.However, imaging showed a deformed stent at left main.The stent delivery system was removed from the guide catheter and it was noted that the stent fell off the balloon.A non-bsc guidewire managed to pass through the lumen of the deformed stent, then the stent moved from the proximal segment to the lad.A 1.20 x 15mm and a 2.0 x 15 mm nc quantum apex balloon catheters were used for stent expansion, but the expansion was only partial.While pulling out the balloon catheter, the partially expanded deformed stent moved into the main stem and proximal segment of the left circumflex artery.Another non-bsc guidewire was advanced through the deformed stent.A 2.5 x 8mm nc quantum apex balloon catheter was advanced but failed to cross the deformed stent.An unsuccessful attempt was made to crush the stent to the left circumflex vessel wall.A snap was not available, another laboratory was contacted to urgently deliver one (clinical hospital center in (b)(6), 15 km distance).Then, imaging indicated thrombosis in the main stem.An extra support guidewire was advanced to the apical segment of lad.Unfortunately, the sudden failure of a machine makes the further procedure impossible.After ten minutes, the patient complained of chest pain and became respiratory insufficient.Then the patient was orotracheally intubated and connected to ventilator support.The patient developed sudden cardiogenic shock therefore intensive inotropic support was given.The patient was urgently transported by ambulance to a different catheterization laboratory to get further therapeutic intervention ((b)(6)).However, after the unsuccessful reanimation at the emergency department of the (b)(6), the patient died.
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Event Description
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It was reported that the patient died.Vascular access was obtained via the right radial and femoral artery.The 90% stenosed, 22x2.5mm, concentric and the de novo target lesion was located in the mildly calcified left anterior descending (lad) artery.A 3.5 (6f) non-bsc guide catheter was advanced in the ostium of the left coronary artery and a non-bsc guide wire was used to cross the significant stenosis of the proximal lad segment.Pre-dilation was performed with a 2.0 x 20mm non-bsc balloon catheter, leaving 30% residual stenosis in the lesion.A 2.50x24mm promus element plus drug-eluting stent was advanced but failed to cross the distal part of the stenosis.The stent was pulled back into the guide catheter with intention to perform a pre-dilatation with a larger balloon size.However, imaging showed a deformed stent at left main.The stent delivery system was removed from the guide catheter and it was noted that the stent fell off the balloon.A non-bsc guidewire managed to pass through the lumen of the deformed stent, then the stent moved from the proximal segment to the lad.A 1.20 x 15mm and a 2.0 x 15 mm nc quantum apex balloon catheters were used for stent expansion, but the expansion was only partial.While pulling out the balloon catheter, the partially expanded deformed stent moved into the main stem and proximal segment of the left circumflex artery.Another non-bsc guidewire was advanced through the deformed stent.A 2.5 x 8mm nc quantum apex balloon catheter was advanced but failed to cross the deformed stent.An unsuccessful attempt was made to crush the stent to the left circumflex vessel wall.A snap was not available, another laboratory was contacted to urgently deliver one (clinical hospital center in rijeka, 15 km distance).Then, imaging indicated thrombosis in the main stem.An extra support guidewire was advanced to the apical segment of lad.Unfortunately, the sudden failure of a machine makes the further procedure impossible.After ten minutes, the patient complained of chest pain and became respiratory insufficient.Then the patient was orotracheally intubated and connected to ventilator support.The patient developed sudden cardiogenic shock therefore intensive inotropic support was given.The patient was urgently transported by ambulance to a different catheterization laboratory to get further therapeutic intervention ((b)(6) hospital).However, after the unsuccessful reanimation at the emergency department of the (b)(6) hospital center, the patient died.It was further reported that when they took out the stent delivery system through the guiding catheter, it was noted that the stent remained in the vessel but was not expanded.The delivery system of the stent stayed alone without the stent before any expansion in the procedure.The previously reported 2.0 x 15 mm nc quantum apex balloon catheter that was used for stent expansion was not a bsc device.It was noted that the patient was transferred to a different catheterization laboratory ((b)(6) hospital) which took a maximum of 20 minutes.While at the emergency department at (b)(6) hospital center, they attempted to reanimate the patient for 45 minutes.The physician stated that the patients death may have been related to the stenting event (un-expansion in the vessel), no snares at that time in the hospital and the angiography tube that stopped working.
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