MICRO THERAPEUTICS, INC. DBA EV3 AXIUM PRIME BRPL HLX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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Model Number APB-2-8-HX-ES |
Device Problem
Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/09/2021 |
Event Type
malfunction
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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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Medtronic received information that an axium coil did not detach.No additional information was received.
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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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Event Description
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Additional information received reported the device was prepared as indicated in the instructions for use (ifu).The user does not use the instant detacher.In the professor's opinion, the age, weight of the patient and anatomy, or the microcatheter used (which was the correct diameter), etc., had no bearing on the verdict regarding the equipment.At the same time, he ensures that the patient has left without a cupboard and feels good.Professor is convinced of the defectiveness of this particular piece of coil.Professor believes that the coil has not released (didn¿t detach) after trying to manually unhook (without id-1-5).On the other hand, other external factors have no influence on the issue of coil not detaching.
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Manufacturer Narrative
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H3: the axium prime coil was returned for analysis.There was no instant detacher and introducer sheath returned with the device.The pusher appeared to be separated on the proximal end with the release wire extending out; along with the ai, coupler tube, positive load indicator and break load indicator were missing and not returned.Therefore, any contributing factors could not be assessed.No bends or kinks were found with the axium prime pusher.Under the microscope, the coin was found to be located against the lumen stop, the shield coil was found to be present, and the implant coil was still attached to the pusher.The implant coil was found damaged and stretched.No other anomalies were observed.The axium prime pusher was not intact the axium prime coil could not be used with an in-house id.Based on the device analysis and reported information, the customer¿s report of ¿non-detachment¿ was confirmed as the axium prime implant coil was returned still attached to the pusher.In this event, the damages found with the pusher (broken/missing) likely contributed to the event causing the implant coil to not detach.Damage to the implant coil and pusher can occur if the user advances the coil against resistance.However, the cause for the damage could not be determined.There was no non-conformance to specification identified that led to the reported issues.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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