Model Number 10622 |
Device Problem
Break (1069)
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Patient Problems
Death (1802); Cardiogenic Shock (2262)
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Event Date 01/23/2020 |
Event Type
Death
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Manufacturer Narrative
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Device is combination product.
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Event Description
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It was reported that a shaft break and death occurred.An emergent percutaneous transluminal coronary angioplasty was being performed.During inflation of the 3.00 x 32mm synergy ii drug-eluding stent balloon, a shaft break occurred at the monorail level in the common core.The patient experienced cardiogenic shock.Intervention was undertaken, including intubation, cardiac massage and an attempt was made to recover the stent and balloon with a snare; however, this was unsuccessful and the patient died.
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Event Description
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It was reported that a shaft break and death occurred.An emergent percutaneous transluminal coronary angioplasty was being performed.During inflation of the 3.00 x 32mm synergy ii drug-eluding stent balloon, a shaft break occurred at the monorail level in the common core.The patient experienced cardiogenic shock.Intervention was undertaken, including intubation, cardiac massage and an attempt was made to recover the stent and balloon with a snare; however, this was unsuccessful and the patient died.Additional information received indicated the lesion was 80% stenosed, very calcified and located in the left main artery.The balloon was inflated to 4 atmospheres when the shaft break occurred and the patient's pressure started to drop.
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Manufacturer Narrative
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Device is combination product.
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Manufacturer Narrative
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Device is combination product.The device was returned for analysis.The middle section of the shaft was broken at two sites.The hypotube lasercut section was partly covered by the broken mid-shaft extrusion and the corewire which had been exposed by the mid-shaft break.There was a break in the proximal hypotube, there was bending of the hypotube at the break site.The portion of the device proximal to the break including a portion of the proximal end of the hypotube and the manifold/hub were not returned.Multiple kinks were noted along the returned portion of hypotube.There was a break in the mid-shaft extrusion in the hypotube lasercut region.The non-returned section included a portion of the mid-shaft extrusion, the port bond area, the distal polymer shaft and the balloon/stent and tip section.At the mid-shaft break site, the hypotube lasercut had been damaged, it appeared twisted and kinked, the lasercut was still held together by the corewire.No other issues were identified during the product analysis.
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Event Description
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It was reported that a shaft break and death occurred.An emergent percutaneous transluminal coronary angioplasty was being performed on an 80% stenosed and very calcified lesion.During inflation of the 3.00 x 32mm synergy ii drug-eluding stent balloon at 4 atmospheres, a shaft break occurred at the monorail level in the common core.The patient experienced a decrease in blood pressure and cardiogenic shock.Intervention was undertaken, including intubation, cardiac massage and an attempt was made to recover the stent and balloon with a snare; however, this was unsuccessful and the patient died.Additional information received indicated the lesion was 80% stenosed, very calcified and located in the left main artery.The balloon was inflated to 4 atmospheres when the shaft break occurred and the patient's pressure started to drop.
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Search Alerts/Recalls
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