Model Number 20226 |
Device Problems
Material Separation (1562); Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/24/2023 |
Event Type
Injury
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Event Description
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It was reported that stent did not fully deploy, and balloon detachment occurred.The patient presented with peripheral artery disease (pad).The stenosed target lesion was located in the moderately tortuous and moderately calcified iliac artery.A 7.0x30x75cm express ld iliac / biliary stent was advanced for treatment.However, the stent did not fully deploy when the physician removed the stent delivery system (sds).The balloon of the sds tore about leaving the balloon in the body.The physician then gained access on the other side and was able to remove the balloon from the body with a snare and the procedure was completed.There were no patient complications nor injuries reported and patient fully recovered.
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Manufacturer Narrative
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Device evaluated by mfr.: express-b-i ld, pmtd.7.0x30x75cm, was returned for analysis.A visual examination of the returned device confirmed that the balloon had been subjected to positive pressure.Blood noted inside the balloon is evidence of a device leak.A leak test could not be carried out due to a complete separation of the shaft.No other issues were noted with the balloon.The device was received with stent fully deployed from the delivery system.The deployed stent was not returned for analysis.A visual examination found the tip of the device to be severely damaged.This type of damage is consistent with the device encountering resistance when crossing/advancing the lesion.A visual and tactile examination found the shaft of the device to be completely separated at the proximal balloon sleeve.This type of damage is consistent with excessive tensile force being applied to the device.
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Event Description
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It was reported that stent did not fully deploy, and balloon detachment occurred.The patient presented with peripheral artery disease (pad).The stenosed target lesion was located in the moderately tortuous and moderately calcified iliac artery.A 7.0x30x75cm express ld iliac / biliary stent was advanced for treatment.However, the stent did not fully deploy when the physician removed the stent delivery system (sds).The balloon of the sds tore about leaving the balloon in the body.The physician then gained access on the other side and was able to remove the balloon from the body with a snare and the procedure was completed.There were no patient complications nor injuries reported and patient fully recovered.
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Search Alerts/Recalls
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