Catalog Number ERES22514X |
Device Problems
Material Deformation (2976); Physical Resistance/Sticking (4012)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 06/14/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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During the procedure, an attempt was made to use one endeavor resolute drug eluting stent to treat a severely tortuous and calcified lesion located in the distal circumflex artery, exhibiting chronic total occlusion ¿ 100%.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues identified.Negative prep was performed with no issues noted.The lesion was pre-dilated.Resistance was encountered when advancing the device.It was reported that the stent failed to cross the lesion.Image attached shows stent deformation.Patient status post-procedure is alive with no injury.
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Manufacturer Narrative
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Please note that this device endeavor resolute is not marketed in the united states, however, the device is deemed the same as the united states marketed device resolute integrity.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Image review: photo 1; image shows a ¿not passing¿ situation statement.Photo 2; image shows an endeavor resolute 2.25mm * 14mm shelf carton, the luer and stent of a device.The lot number printed on the luer of the device corresponds with the lot number on the shelf carton and the lot number on gch.Deformation is evident to the stent wraps with the struts appearing raised.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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