Lot Number 0030159408 |
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 01/09/2024 |
Event Type
malfunction
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Event Description
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It was reported that the stent got entrapped in the guide extension.The stenosed target lesion was located in the mildly tortuous and moderately calcified artery.A 3.50 x 12mm synergy xd drug-eluting stent was advanced for treatment.However, during insertion of the device the stent got stuck in the guide extension.Upon trying to pull out the device, the struts of the stent were damaged.The procedure was completed via alternative method.There were no patient complications nor injuries reported.
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Manufacturer Narrative
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E1 initial reporter phone: (b)(6).
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Event Description
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It was reported that the stent got entrapped in the guide extension.The stenosed target lesion was located in the mildly tortuous and moderately calcified artery.A 3.50 x 12mm synergy xd drug-eluting stent was advanced for treatment.However, during insertion of the device the stent got stuck in the guide extension.Upon trying to pull out the device, the struts of the stent were damaged.The procedure was completed via alternative method.There were no patient complications nor injuries reported.
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Manufacturer Narrative
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E1 initial reporter phone: (b)(6).Device evaluated by mfr.Synergy xd mr us 3.50 x 12mm stent delivery system (sds); catheter was returned for analysis.Visual, tactile, microscopic and dimensional testing was performed on the device.A visual, tactile examination identified no issues with the hypotube shaft.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.A microscopic examination identified no issues with the hypotube shaft.A microscopic examination of the outer and inner lumen and mid-shaft section found no issues.Examination of the crimped stent via scope found evidence of stent damage.The proximal edge of the crimped stent had its struts lifted and bunched.There were no signs of movement and the stent was set between the proximal and distal markerbands.A microscopic examination of the bumper tip showed no signs of distal tip damage.The crimped stent od (outer diameter) was measured and was within maximum crimped stent profile measurement.No other device issues were identified during returned product analysis.
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Search Alerts/Recalls
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