Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Reocclusion (1985); Patient Problem/Medical Problem (2688)
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Event Date 02/11/2016 |
Event Type
Death
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Manufacturer Narrative
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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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It is reported that approximately 7.5 months post use of powercross devices re-occlusion of the right femoropopliteal axis occurred.The patient was treated approximately one month later with four non-medtronic pta balloon catheters.The event is reported to be re solved.
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Manufacturer Narrative
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It is reported that approximately 12.5 months post use of powercross devices, patient death occurred.Patient death is reported as an outcome to delirium.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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Manufacturer Narrative
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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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Search Alerts/Recalls
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