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Model Number 9553 |
Device Problems
Entrapment of Device (1212); Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported that device entrapment occurred.The patient presented with late st-elevation myocardial infarction (stemi).Emergency coronary angiography showed 99% stenosed, sub-occluded lesion in the middle segment and occlusion in the distal segment of the circumflex artery.Following pre-dilatation, a 32 x 2.25 promus premier drug-eluting stent was advanced for treatment.However, during introduction, the stent got stuck with the guidewire.The entire system was removed and it was noted that the delivery system was totally damaged.The procedure was completed with another of same device.No patient complications were reported.
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Event Description
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It was reported that device entrapment occurred.The patient presented with late st-elevation myocardial infarction (stemi).Emergency coronary angiography showed 99% stenosed, sub-occluded lesion in the middle segment and occlusion in the distal segment of the circumflex artery.Following pre-dilatation, a 32 x 2.25 promus premier drug-eluting stent was advanced for treatment.However, during introduction, the stent got stuck with the guidewire.The entire system was removed and it was noted that the delivery system was totally damaged.The procedure was completed with another of same device.No patient complications were reported.
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Manufacturer Narrative
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E1.Initial reporter facility name: hospital.The promus premier ous mr 32 x 2.25 stent delivery system (sds) was returned for analysis.An examination of the crimped stent found that the stent was damaged on almost its entire length.Stent struts from proximal to mid stent were lifted and bunched in the mid stent region.Stent struts from the distal region were lifted and pulled distally.A review of the manufacturing stent profile data was performed and the stent outer diameter at the time of manufacture was within max crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks along the length of the hypotube shaft.A visual and tactile examination of the inner, outer and mid-shaft sections found the inner and outer shaft to be flattened/damaged and kinked.A break in the shaft extrusion was also noted at the exchange port.No other issues were identified during the product analysis.
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Search Alerts/Recalls
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