The patient's death was unrelated to the stellarex device.Source documents state the patient expired due to infarction of the right anterior and middle cerebral artery.This is being reported as a follow-up to the clinical study.Patient information regarding relevant tests or laboratory data are unknown.This information was not available from the facility.The patient's death was unrelated to the stellarex device or procedure, thus the paclitaxel drug did not cause or contribute to the patient¿s death.Serial number is unknown.This information was not collected during the study.Udi and pma numbers are not applicable.This device was used in clinical application prior to being available in the us.Study name: foreign- (b)(6) / saver- patient id (b)(6).Combination product is applicable.During the index procedure, the product worked as intended, thus no product evaluation was required.Per the ifu, death is listed as a potential complications/adverse events.
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On (b)(6) 2016, the patient underwent an index procedure of a severely calcified 10 mm, 70% stenotic denovo lesion of the right mid-sfa.The lesion was predilated using a pta balloon and inflated for 1 minute.Then, a 5 x 40 mm stellarex balloon was inflated for 3 minutes, resulting in a residual 005% stenosis.No complications occurred.The patient was discharged per plan.On (b)(6) 2017, the patient was hospitalized for a stroke and died.Source documents state the patient expired on (b)(6) 2017, due to infarction of the right anterior and middle cerebral artery.
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