MICRO THERAPEUTICS, INC. DBA EV3 AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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Model Number APB-4-8-3D-SS |
Device Problems
Break (1069); Unintended Movement (3026)
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Patient Problems
Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/15/2022 |
Event Type
malfunction
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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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Medtronic received information regarding an axium coil that was difficult to detach by manual method.The patient was undergoing a coil embolization procedure to treat a ruptured saccular ophthalmic artery aneurysm.The aneurysm max diameter was 5.17mm and the neck diameter was 2.8mm.Blood flow and vessel tortuosity were normal.It was reported that the axium coil and all accessory devices were prepared as indicated in the instructions for use (ifu).The coil was delivered and manual detachment was attempted but found to be difficult.Three attempts were made and the surgeon had to repeated push and pull the pusher; finally the coil detached.No attempt was made to detach the coil with an instant detacher (id).After the detachment, a portion of the coil was still outside the aneurysm cavity.The surgeon used the pusher to push the coil into the aneurysm and the procedure was completed.There was no harm or injury to the patient.
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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.
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Event Description
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Additional information received reported that there was no damage observed to the coil pusher after it was removed from the patient.
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Manufacturer Narrative
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H3.Product analysis: equipment used: video inspection system (m-78210), ruler 200cm (m-83361), camera (panasonic lumix dmc-zs5) as found condition: the axium prime pushwire was returned for analysis within a shipping box; within a plastic bio-pouch; and within an opened axium prime inner pouch.Visual inspection/damage location details: the axium prime pushwire was found to be broken at break indicator and retained by released wire.The axium prime pushwire was appeared to be tangled very tight.The axium prime implant coil was found to be detached from pushwire and not returned for analysis.No other anomalies were observed.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil stretch¿ could not be confirmed and the root cause could not be determined.Possible causes of failure: patient¿s vessel tortuosity, catheter tip under stress, catheter kick back and catheter placement.The patient¿s vessel tortuosity was normal.It was reported that the axium coil and all accessory devices were prepared as indicated in the instructions for use (ifu).Information regarding catheter tip under stress, catheter kick back and catheter placement were not reported.Therefore, any contributing factors could not be assessed.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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