Model Number 10617 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/08/2022 |
Event Type
Injury
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Manufacturer Narrative
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Initial reporter address: (b)(6).
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Event Description
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It was reported that stent fracture occurred.The 75% stenosed target lesion was located in the non-tortuous and non-calcified left main artery.A 5.00 x 12 synergy drug-eluting stent was advanced for treatment.However, when the stent balloon was inflated, the stent was fractured in the middle.The stent was implanted and the physician completed the procedure by using another stent to cover the fracture.There were no patient complications reported and the patient status was stable.
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Event Description
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It was reported that stent fracture occurred.The 75% stenosed target lesion was located in the non-tortuous and non-calcified left main artery.A 5.00 x 12 synergy drug-eluting stent was advanced for treatment.However, when the stent balloon was inflated, the stent was fractured in the middle.The stent was implanted and the physician completed the procedure by using another stent to cover the fracture.There were no patient complications reported and the patient status was stable.
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Manufacturer Narrative
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E1 initial reporter address 1: (b)(6).Device evaluated by mfr.: (media review) a review of the images provided could not identify the alleged stent fracture however, a gap which could indicate strut displacement was noted in the mid stent region.The distal end of the guide catheter was also noted to be inside the deployed stent in one of the images.The apparent strut displacement noted could have been appeared to the physician as stent fracture however this was not the case as the displaced struts visible in the photo review most likely represent a stent deformation induced by a possible interaction with ancillary devices use during the procedure.This allows the stent to conform (through the 5-connector proximal (first 2 rows) and 2 connectors throughout and in the distal section design to the vessel anatomy and provide the required scaffolding without any straightening of the vessel.Additionally the coplanar view from which we are seeing the stent could mislead to assume that there is a stent fracture when in fact what we are seeing is two strut connectors on the same plane on view (one behind the other), and this would be consistent with the stent image reviewed where struts are displaced in a v shape and connected in a central point.H3 other text : media.
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Manufacturer Narrative
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(e1) initial reporter address 1: (b)(6).Device evaluated by mfr.: (media review) a review of the images provided could not identify the alleged stent fracture however, a gap which could indicate strut displacement was noted in the mid stent region.The distal end of the guide catheter was also noted to be inside the deployed stent in one of the images.The apparent strut displacement noted could have been appeared to the physician as stent fracture however this was not the case as the displaced struts visible in the photo review most likely represent a stent deformation induced by a possible interaction with ancillary devices use during the procedure.This allows the stent to conform (through the 5-connector proximal (first 2 rows) and 2 connectors throughout and in the distal section design to the vessel anatomy and provide the required scaffolding without any straightening of the vessel.Additionally the coplanar view from which we are seeing the stent could mislead to assume that there is a stent fracture when in fact what we are seeing is two strut connectors on the same plane on view (one behind the other), and this would be consistent with the stent image reviewed where struts are displaced in a v shape and connected in a central point.
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Event Description
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It was reported that stent fracture occurred.The 75% stenosed target lesion was located in the non-tortuous and non-calcified left main artery.A 5.00 x 12 synergy drug-eluting stent was advanced for treatment.However, when the stent balloon was inflated, the stent was fractured in the middle.The stent was implanted and the physician completed the procedure by using another stent to cover the fracture.There were no patient complications reported and the patient status was stable.It was further reported that the target lesion was pre-dilated with a 4.0x6mm semi-compliant balloon catheter at 18 atmospheres.Additionally, the stent fracture occurred immediately after deployment and the broken struts were visible under fluoroscopy.
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Search Alerts/Recalls
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