Catalog Number RSINT22508UX |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Date 04/25/2016 |
Event Type
Injury
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Manufacturer Narrative
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Event date- month and year valid only.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The physician used a resolute integrity drug-eluting stent in the proximal lad, lesion exhibited little tortuosity.The device was removed from packaging and inspected with no issues noted.No resistance was encountered when advancing the device.The stent did not pass through a previously deployed stent.A longer stent of the same size was placed in a lesion without difficulty.After placement there was narrowing proximal to the stent.The stent in question was placed proximal to the original stent and expanded.After removing the balloon and injecting dye the stent was not where it had been deployed.It is reported that initial deployment was 10 atms and adequate deflation time was allowed prior to the physician removing the balloon of the reported stent delivery system.It was found at the distal most portion of the vessel (20-30 mm back).The dr tried to move the stent with a partially inflated balloon and when he was unable he expanded the stent in its new location without difficulty and placed another stent in the lesion.
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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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Search Alerts/Recalls
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