Lot Number 0029640478 |
Device Problems
Entrapment of Device (1212); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/05/2024 |
Event Type
malfunction
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Event Description
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It was reported that the entrapment of the device occurred.The target lesion was located in the left anterior descending (lad) artery.The physician used a non-boston scientific guidewire pressure to the lesion.A 2.75 x 38mm synergy xd drug-eluting stent was advanced to treat the lesion.However, during the procedure, the stent was stuck into the guidewire and could not be advanced nor removed.As it was tried to removed from the wire, the stent was deformed.Both devices were removed as one unit.The procedure was completed with a non-boston scientific device.There were no patient complications reported.
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Event Description
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It was reported that the entrapment of the device occurred.The target lesion was located in the left anterior descending (lad) artery.The physician used a non-boston scientific guidewire pressure to the lesion.A 2.75 x 38mm synergy xd drug-eluting stent was advanced to treat the lesion.However, during the procedure, the stent was stuck into the guidewire and could not be advanced nor removed.As it was tried to removed from the wire, the stent was deformed.Both devices were removed as one unit.The procedure was completed with a non-boston scientific device.There were no patient complications reported.
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Manufacturer Narrative
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Device evaluated by mfr.: synergy xd mr us 2.75 x 38mm, catheter was returned for analysis.The device was returned to the cis for analysis.A visual, tactile, microscopic and device to device interaction test was performed.An examination of the returned device identified that the extrusion was stretched and accordioned.As a result of the extrusion damage, the extrusion was stretched down onto the 0.014inch size wire (guidewire measured using a snap gauge at 0.014inch).As a result, it was not possible to remove the guidewire from the device.A microscopic examination of the crimped stent identified that the proximal to mid section of the crimped stent was bunched with stent struts misaligned.No other damages were present along the device.
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Search Alerts/Recalls
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