| Model Number 10622 |
| Device Problems
Break (1069); Difficult to Remove (1528)
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| Patient Problems
Death (1802); Perforation (2001); Stenosis (2263); Device Embedded In Tissue or Plaque (3165); Pericardial Effusion (3271)
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| Event Date 01/01/2021 |
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Event Type
Death
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Manufacturer Narrative
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(b)(6).
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Event Description
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Reported via (b)(6) report: it was reported that difficult to remove a stent, shaft break, perforation, pericardial effusion, un-retrieved device fragment, and death occurred.A 3drc - 4f catheter and a jl 3.0-6 f guiding catheter was used to catheterize the left and right networks.There was difficult catheterization of the left coronary artery.Selective opacification of the right coronary was a first step then changed to a 6f and opacification of the left coronary artery with difficulty with the non boston scientific (bsc) guiding catheter (failure of non bsc catheters).Catheterization of the left coronary artery was successful with the non bsc guide catheter was successful, a 0-6 f and a non bsc guidewire was used to stabilize the device, guidewire that was placed in the proximal lad.The target lesion was located in the massively calcified left anterior descending artery (lad).Long subocclusive stenosis of the proximal lad about 30mm long.Then significant stenosis at 70% very calcified of the average lad compared to the start of a diagonal of good caliber.This diagonal artery did not present any significant lesion.Tight stenosis at 80-90% at the level of the post diagonal mid lad then significant stenosis at 70-80% of the mid lad then significant stenosis at 70-80% of the mid lad over 30 mm in length.The distal lad was of good caliber without significant lesion.The lad is in timi 2 to 3 flow.Subocclusion of a multiple diseased medium caliber septal.The circumflex marginal was the dominant network, marked with atheroma.There was recent looking occlusion of the distal circumflex artery and had a timi artery flow 1.There was chronic occlusion of the middle right coronary artery partially hemo collateralized, and was a dominated artery.A decision made for angioplasty of the lad first taking into account the ecg aspect of anterior hypokinesia, of the beautiful area.A jl 3.0 - 6 french guide catheter was used.A placement of a non boston scientific (bsc) guidewire was advanced distally of the diagonal, for protection, without difficulty.A non bsc guide was placed distally from the lad.A predilation was performed on the post diagonal mid lad, of the mid lad and the proximal ostial lad with a 2.0 x 15mm semi compliant non bsc balloon inflated in a tiered fashion at 12 atmospheres, but had an incomplete result.An imprint at the level of the proximal lad where the balloon slides systematically had remained.A 2.5 x 15mm non bsc non compliant balloon was inflated in a tiered fashion at 14 am at the mid lad level with good expansion.The balloon was inflated at 24 atm four times for 30 seconds at the proximal lad level with persistence of an imprint and 90% stenosis at the level of the proximal lad.Complementary predilation was performed on the proximal lad with a 3.0 x 15mm non bsc non compliant balloon at 20 atm for 30 seconds, and resulted in good expansion of the balloon.Complementary predilation of the mid lad and the of the ostium of the mid lad post diagonal with the same balloon at 12 atmospheres.A 2.5 x 38mm synergy stent was advanced and implanted at the level of the mid lad, covering the start of the diagonal at 12 atm, and had a satisfactory result.Complementary predilation was performed on the proximal lad with the balloon carrying the stent at 18 atm.A non bsc guidewire was used and the stent struts crossed the diagonal without difficulty.After removing the trapped non bsc guidewire, a 2.0 x 15mm non bsc balloon was advanced and inflated to open the stent struts toward the diagonal.The non bsc guidewire was then positioner towards the circumflex for protection.A 3.50 x 32 synergy stent was advanced to the proximal and middle ostial lad, inflated at 11 atmospheres for 20 seconds and deployed, overlapping the previous stent implanted distally.The proximal segment of the stent was positioned at the level of the ostium of the lad.A mid lad perforation by controlling the result while the balloon was carrying the stent was still in place.An emergency re inflation of the balloon to 16 atm to seal the breach at the level of the mid lad was performed.A perforation with leakage of contrast agent towards the pericardium was noted.An emergency cardiac ultrasound was performed which noted the appearance of non compressive pericardial effusion of 8 to 9 mm circumference.A filling with gelofusine was performed and supported by aminergic by noradrenaline and adrenaline.Preparation of a 3.5 x 15mm papyrus covered stent occurred.It was noted that it was made sure that during the preparation of the covered stent that the stent carrying balloon was occlusive, preventing extravasation of contrast medium through the perforation.An attempt to position the non bsc guidewire, located in the circumflex toward the distal lad, was made, but this guide did not orient in the distal lad.While removing the balloon carrying the stent, resistance was noticed.The hypotube broke at the level of the junction with the balloon carrying stent.The balloon carrying the stent remained stuck in the proximal lad.It was noted that it was impossible to bring the covered stent into the proximal lad to cover the perforation.The patient died.It was further reported that a complicated coronary angioplasty procedure of a coronary perforation was performed.When removing the balloon carrying stent, a feeling of resistance was noticed.The hypotube broke at the level of punction with the balloon carrying stent.The balloon carrying stent remained stuck in the proximal lad.It was impossible to bring the covered stent into the proximal lad to cover the perforation.The current status of the patient is patient death.
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Manufacturer Narrative
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Device returned to manufacturer: a synergy ous mr 3.50 x 32 stent delivery system was retuned for analysis.The distal section of the device was not returned.No analysis carried out on distal tip, stent, inner/outer polymer extrusion or balloon sections.A visual and tactile examination of the hypotube found multiple kinks a visual and tactile examination of the mid-shaft section found a break in the midshaft region measuring at 123cm distal to the distal end of the strain relief as well as stretching beginning at the port pond and extending 3.5cm distally.No other issues were identified during the product analysis.E1: initial reporter address 1: (b)(6).
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Event Description
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Reported via ansm report: it was reported that difficult to remove a stent, shaft break, perforation, pericardial effusion, unretrieved device fragment, and death occurred.A 3drc - 4f catheter and a jl 3.0-6 f guiding catheter was used to catheterize the left and right networks.There was difficult catheterization of the left coronary artery.Selective opacification of the right coronary was a first step then changed to a 6f and opacification of the left coronary artery with difficulty with the non boston scientific (bsc) guiding catheter (failure of non bsc catheters).Catheterization of the left coronary artery was successful with the non bsc guide catheter was successful, a 0-6 f and a non bsc guidewire was used to stabilize the device, guidewire that was placed in the proximal lad.The target lesion was located in the massively calcified left anterior descending artery (lad).Long subocclusive stenosis of the proximal lad about 30mm long.Then significant stenosis at 70% very calcified of the average lad compared to the start of a diagonal of good caliber.This diagonal artery did not present any significant lesion.Tight stenosis at 80-90% at the level of the post diagonal mid lad then significant stenosis at 70-80% of the mid lad then significant stenosis at 70-80% of the mid lad over 30 mm in length.The distal lad was of good caliber without significant lesion.The lad is in timi 2 to 3 flow.Subocclusion of a multiple diseased medium caliber septal.The circumflex marginal was the dominant network, marked with atheroma.There was recent looking occlusion of the distal circumflex artery and had a timi artery flow 1.There was chronic occlusion of the middle right coronary artery partially hemo collateralized, and was a dominated artery.A decision made for angioplasty of the lad first taking into account the ecg aspect of anterior hypokinesia, of the beautiful area.A jl 3.0 - 6 french guide catheter was used.A placement of a non boston scientific (bsc) guidewire was advanced distally of the diagonal, for protection, without difficulty.A non bsc guide was placed distally from the lad.A predilation was performed on the post diagonal mid lad, of the mid lad and the proximal ostial lad with a 2.0 x 15mm semi compliant non bsc balloon inflated in a tiered fashion at 12 atmospheres, but had an incomplete result.An imprint at the level of the proximal lad where the balloon slides systematically had remained.A 2.5 x 15mm non bsc non compliant balloon was inflated in a tiered fashion at 14 am at the mid lad level with good expansion.The balloon was inflated at 24 atm four times for 30 seconds at the proximal lad level with persistence of an imprint and 90% stenosis at the level of the proximal lad.Complementary predilation was performed on the proximal lad with a 3.0 x 15mm non bsc non compliant balloon at 20 atm for 30 seconds, and resulted in good expansion of the balloon.Complementary predilation of the mid lad and the of the ostium of the mid lad post diagonal with the same balloon at 12 atmospheres.A 2.5 x 38mm synergy stent was advanced and implanted at the level of the mid lad, covering the start of the diagonal at 12 atm, and had a satisfactory result.Complementary predilation was performed on the proximal lad with the balloon carrying the stent at 18 atm.A non bsc guidewire was used and the stent struts crossed the diagonal without difficulty.After removing the trapped non bsc guidewire, a 2.0 x 15mm non bsc balloon was advanced and inflated to open the stent struts toward the diagonal.The non bsc guidewire was then positioner towards the circumflex for protection.A 3.50 x 32 synergy stent was advanced to the proximal and middle ostial lad, inflated at 11 atmospheres for 20 seconds and deployed, overlapping the previous stent implanted distally.The proximal segment of the stent was positioned at the level of the ostium of the lad.A mid lad perforation by controlling the result while the balloon was carrying the stent was still in place.An emergency re inflation of the balloon to 16 atm to seal the breach at the level of the mid lad was performed.A perforation with leakage of contrast agent towards the pericardium was noted.An emergency cardiac ultrasound was performed which noted the appearance of non compressive pericardial effusion of 8 to 9 mm circumference.A filling with gelofusine was performed and supported by aminergicby noradrenaline and adrenaline.Preparation of a 3.5 x 15mm papyrus covered stent occurred.It was noted that it was made sure that during the preparation of the covered stent that the stent carrying balloon was occlusive, preventing extravasation of contrast medium through the perforation.An attempt to position the non bsc guidewire, located in the circumflex toward the distal lad, was made, but this guide did not orient in the distal lad.While removing the balloon carrying the stent, resistance was noticed.The hypotube broke at the level of the junction with the balloon carrying stent.The balloon carrying the stent remained stuck in the proximal lad.It was noted that it was impossible to bring the covered stent into the proximal lad to cover the perforation.The patient died.It was further reported that a complicated coronary angioplasty procedure of a coronary perforation was performed.When removing the balloon carrying stent, a feeling of resistance was noticed.The hyotube broke at the level of punction with the balloon carrying stent.The balloon carrying stent remained stuck in the proximal lad.It was impossible to bring the covered stent into the proximal lad to cover the perforation.The current status of the patient is patient death.
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