Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, ethnicity, and medical history were not provided.Date of event: the date of the event/study is not known.He product catalog and lot numbers are not available / not reported.The expiration date of the device is not known.Information such as initial reporter facility name, address, city, state, name, phone and email address are not available / reported.The device manufacture date is not known as the product lot number of the device is not available / not reported.[conclusion]: it was reported through the database research activities, the single-arm study outcomes associated with the use of enterprise stent for endovascular treatment among patients with unruptured intracranial aneurysm, there were 19 patients who were considered to have neurologic complication if they had the relevant international classification of diseases (icd)-9/10 codes listed during the admission period.No other information is available.Based on complaint information, the device was not available to be returned for analysis.The device lot number was not available.The device history record (dhr) review could not be performed without the lot number.Product analysis cannot be conducted as the product was not returned for analysis.In addition, there was no report of malfunction associated with the device.As such, the investigation will be closed.With very limited information, the cause of the neurologic complication in the 19 patients is not known.There was no information on patient medical history, and no information on the device and its performance during use in the study procedure.The device catalog and lot numbers are not known; therefore, the determination of possible device-related causes cannot be determined through device analysis or through device history record review.The exact cause of the event could not be conclusively determined.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.This is one of four products involved with the reported complaint.The associated manufacturer report numbers are: 1226348-2019-01036, 1226348-2019-01037, 1226348-2019-01038, and 1226348-2019-01039.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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It was reported through the database research activities, the single-arm study outcomes associated with the use of enterprise stent for endovascular treatment among patients with unruptured intracranial aneurysm, there were 19 patients who were considered to have neurologic complication if they had the relevant international classification of diseases (icd)-9/10 codes listed during the admission period.No other information is available.
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