Model Number AA14SX040080150 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thrombus (2101)
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Event Date 12/12/2018 |
Event Type
Injury
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Manufacturer Narrative
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Adverse event/outcomes to adverse event: the patient required intervention of the treated lesion.This is being reported as a part of a clinical study.Report source: foreign: (b)(6).Study name: (b)(6) - patient id # (b)(6).Pma/510k: pma number is not applicable.The device is a commercial product with a ce mark that was used as part of a clinical study.Device evaluated by mfr: during the index procedure, the product worked as intended, thus no product evaluation was required.Per the ifu, thrombosis is listed as a potential complications/adverse events.
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Event Description
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It was reported through a clinical study that during the index procedure on (b)(6) 2018, three stellarex catheters were used to treat the target lesion of the right p3 and tp.After the procedure, the patient experienced thrombus inflow on the target lesion, thus stent placement was required.
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Manufacturer Narrative
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Block d4: model and catalog number corrected from a14sx040080150t to aa14sx040080150.H3 other text : placeholder.
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Search Alerts/Recalls
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