Model Number A35SX060120135 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cancer (3262); Insufficient Information (4580)
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Event Date 03/19/2019 |
Event Type
Death
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Manufacturer Narrative
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The patient's date of birth is unknown.This information was not available from the facility.Foreign report source: (b)(6).Pma number is not applicable.The device is a non-commercial product with a ce mark that was used as part of a clinical study.During the index procedure, the product worked as intended and the device was discarded, thus no product evaluation was performed.Although the cause of death is unrelated to the study device, death is listed in the ifu 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) 2019, three stellarex catheters (3011416935-2022-00005, 3011416935-2022-00006) were used to treat the target lesion of the left proximal, mid, and distal sfa.Approximately 36 months post index procedure, it was reported that the patient expired.The date and cause of death is unknown.The physician indicated this is not related to the study device or procedure.This adverse event is being submitted because the patient expired.The cause of death is unknown, however it was not related to the study device or procedure.This is being reported as a follow-up to the clinical study.
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Manufacturer Narrative
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Block b5: updated to add clinical evaluation and cause of death.
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Event Description
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Approximately 20 months post index procedure, it was reported that the patient was diagnosed with lung cancer.Per clinical evaluation, the patient likely died from cancer and/or complications of chemotherapy related to the cancer.
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Search Alerts/Recalls
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