Model Number AA14SX025150150 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Death (1802)
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Event Date 07/05/2019 |
Event Type
Death
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Manufacturer Narrative
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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.Cross reference mfr report numbers: 3009784280-2021-00013, 3009784280-2021-00014.Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.Report source: foreign- (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.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 registry that during the index procedure on (b)(6) 2019, three stellarex catheters were used to treat the target lesion of the right infrapopliteal, proximal peroneal, and proximal, distal anterior tibialis.Approximately 19 months post index procedure, the patient expired due to covid-19 infection on (b)(6) 2021.The physician indicated this is not related to the study device or procedure.
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Manufacturer Narrative
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Manufacturer received an email from fda on 15 mar 2021 providing a list of mdr''s submitted by the manufacturer that included an invalid exemption number.The purpose of this supplemental report is to clarify that the mdr submitted is not the subject of an approved exemption and therefore number ¿5645646¿ included in the ¿exemption number¿ field was submitted in error.This exemption number has now been removed.
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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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