Catalog Number ERES25014X |
Device Problems
Failure to Advance (2524); Device Dislodged or Dislocated (2923); 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 05/06/2018 |
Event Type
malfunction
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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, it is similar to the united states marketed product (resolute integrity).If information is provided in the future, a supplemental report will be issued.
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Event Description
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Four endeavor resolute drug-eluting stents were intended to be used to treat a lesion in the mid lad / diagonal branch with severe calcification, severe tortuosity and 90% lesion stenosis.There was no damage noted to packaging.No issues noted when removing the devices from the hoop.The devices were inspected with no issues noted.Negative prep was performed with no issues noted.The devices passed through a previously deployed stent.Resistance was encountered when advancing.The lesion was pre-dilated.The first stent was placed in the anterior descending branch and it was reported that it was unable to pass through the calcified lesion.The stent was removed, further dilation was applied and another stent was used.The second stent also failed to cross the lesion.The third stent became dislodged after failing to cross the lesion.This stent was expanded in situ.The fourth stent was used to support the implanted stent but it was unable to pass the previous stent.This stent was also deployed.The patient is alive with no injury reported.
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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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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Correction: the second stent (2.5x14mm endeavor resolute) dislodged, not the third stent (2.5x30mmendeavor resolute).If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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