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Model Number NV UNK PIPELINE |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problems
Hemorrhage/Bleeding (1888); Hemorrhage, Cerebral (1889); Intracranial Hemorrhage (1891); Seizures (2063); Pseudoaneurysm (2605); Convulsion/Seizure (4406)
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Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Griffin a, reese v, hüseyinoglu z, et al.Predictors of clinical outcome after treatment of intracranial aneurysms with the pipeline embolization device. world neurosurgery.2019;130:e666-e671.Doi:10.1016/j.Wneu.2019.06.185.Medtronic received a literature article pertaining to a study to identify predictors of adverse events associated with the pipeline.In this study the mean age was 56.3, 80% female.The study took place between january 2014 and september 2018.204 aneurysms in 170 patients were treated with the pipeline.181 aneurysms were located in the anterior circulation, and 23 were found in the posterior circulation.82% of aneurysms were saccular, followed by 11% fusiform and 4% blister.(11%).The mean aneurysm size was 8.2mm.The overall complication rate was 13.5%.These complications included 5 strokes, 3 intraparenchymal hemorrhages, 3 groin hematomas, 2 retroperitoneal hematomas, 2 health care associated pneumonia.2 in-stent thrombosis.2 vessel perforations, 1 retinal artery occlusion.1 seizure, 1 groin pseudoaneurysm, and 1 aneurysm rupture.The major neurologic morbidity rate was 4.7%, occurring in 8 patients.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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