Model Number A35SX060040080 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Heart Failure/Congestive Heart Failure (4446)
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Event Date 05/25/2018 |
Event Type
Death
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Manufacturer Narrative
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The patient's weight, ethnicity, and race are unknown.This information was not available from the facility.The patient's cause of death was unrelated to the study device or procedure.This is being reported as a follow-up to the clinical registry.Patient information regarding relevant tests/ laboratory data is unknown.This information was not available from the facility.Report source: foreign - (b)(6)/ study name: (b)(6): patient id # (b)(6).Pma number is not applicable.The device is a commercial product with a ce mark that was used as part of a clinical registry.During the index procedure, the product worked as intended and the device was discarded, thus no product evaluation was required.(b)(4).
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Event Description
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It was reported through a clinical registry that during the index procedure on (b)(6) 2018, a stellarex catheter was used to treat the target lesion of the left proximal sfa.Approximately 24 months post index procedure, the patient expired due to cardiopulmonary decompensation on (b)(6) 2020.The physician indicated this is not related to the study device or procedure.
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Manufacturer Narrative
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Block h6: added code 1802 (death).Although the cause of death is unrelated to the study device, death is listed in the ifu as a potential complications/ adverse events.Component codes intentionally left blank.No device malfunction was reported during the index procedure.
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Manufacturer Narrative
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Block h1 (no.Of events (noe) summarized): in the initial report, the xml file shows the summary report and 123 events were included.However, this was inadvertently included due to a system error in the xml file, as it was not visible in the pdf copy.This field should be left blank.
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Search Alerts/Recalls
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