Product event summary: a pump with unknown serial number was not returned for evaluation.The reported low flow event was not confirmed via review of the controller log files since log files covering the reported event date were not available for analysis.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Based on risk documentation, multiple factors may have contributed to the low flow event including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, poor vad filling, inappropriate pump rotational speed, incorrect positioning of the pump during implant.Possible clinical factors that may have contributed to this event include the patients pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.Concomitant medical products: brand name: heartware ventricular assist system outflow graft.Model #: unk / catalog #: unk / expiration date: unk / serial or lot#: unk udi #: asku.Device available for evaluation: no.Mfg date: unk.Labeled for single use: no.(b)(4).This event was reported in the q3 2020 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support.The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event.Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.If information is provided in the future, a supplemental report will be issued.
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