Model Number GLX120206 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Aneurysm (1708)
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Event Date 11/17/2021 |
Event Type
Injury
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Event Description
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As reported by the sterling study, a (b)(6) female (subject (b)(6)) with a history of active smoking and intracranial aneurysm underwent coil embolization of an unruptured left posterior communicating artery aneurysm on (b)(6) 2021 and experienced intraoperative aneurysm perforation.Balloon occlusion was performed as intervention, and the event required prolonged hospitalization.The patient is recovering from the event.The event was classified as severe.Per the principal investigator (pi), the event was related to the study device.The event was considered serious.
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Manufacturer Narrative
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Product complaint # (b)(4).Patient identifier: (b)(6).The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30522162 number, and no non-conformances related to the malfunction were identified.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 company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.This is one of four products involved with the complaint and the associated manufacturer report numbers are 3008114965-2021-00671, 3008114965-2021-00672 and 3008114965-2021-00673.
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Manufacturer Narrative
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Product complaint # = > (b)(4).Updated sections on this medwatch report: b4, b5, g3, g6, h2, h6 and h10.Section b5: modified information on the clinical research form (crf) indicated the following: endovascular intervention value "no¿ was changed to ¿yes¿.Remodeling balloon was positioned and inflated to treat the aneurysm perforation.Medication complete/update concomitant medications log value "no¿ was changed to ¿yes¿.Protamine was administered to reverse the heparin.Discharge date value "" was changed to (b)(6) 2021.Section h6: health effect - impact code: medication required additional information is pending as to whether the perforation was associated with the target aneurysm.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
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Search Alerts/Recalls
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