MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER
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Model Number PED2-350-25 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 12/06/2021 |
Event Type
Injury
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Event Description
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Medtronic received a report that after fully deploying the pipeline device, the physician was unable to retrieve the pipeline pusher, including the tip wire.They think the device was stuck into the pca perforator, resulting in the pipeline retrieval failure.No catheter damage was discovered.The patient was undergoing surgery for treatment of a fusiform, unruptured aneurysm in the left va with a max diameter of 4mm.It was noted the patient's vessel tortuosity was moderate.There were no patient symptoms or complications associated with the event.A dapt (dual antiplatelet treatment) was administered and the pru level was unknown.The pipeline was not used for an indication that was not approved.The pipeline and accessory devices were prepared as indicated in the ifu. ancillary devices include: an envoy 6, a phenom 27, and a synchro 14.
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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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Manufacturer Narrative
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B5.Updated with additional information received.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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Event Description
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Additional information received reported pipeline pushwire break/separation was not observed.
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Search Alerts/Recalls
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