MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER
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Model Number PED2-450-16 |
Device Problem
Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/16/2020 |
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 a report that the pipeline failed to open distally.The patient was undergoing treatment for an unruptured aneurysm located in the internal carotid artery.The patient¿s vessel tortuosity was severe.It was reported that there was bad deployment in the distal part of the device despite normal deployment maneuvers.The doctor had resheathed the pipeline more than two times.The pipeline was replaced.Angiographic results post procedure were said to be good, and their status was alive with no injury.The devices were prepared according to the instructions for use (ifu).Ancillary devices include sofia + 6f guide catheter and a phenom 27 microcatheter.
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Manufacturer Narrative
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H3: analysis of the pipeline flex embolization device (model: ped2-450-16, lot: b087995) found that upon visual inspection, no bends or kinks were found with the pushwire.The hypotube and ptfe were found to be intact.The proximal bumper, re-sheathing marker and re-sheathing pad were found to be intact.The dps sleeves were found to be intact.The tip coil was found to be intact.Due to the condition in which the braid was returned the distal and proximal ends could not be determined.Both ends of the pipeline flex braid were found fully collapsed and frayed.No other damages or anomalies were found with the device.Based on the device analysis and reported information, the customer¿s report of ¿failure/incomplete to open distal¿ was unable to be confirmed as both ends of the pipeline flex braid were found to be fully opened and frayed.The customer reported having re-sheathed the device more than 2 times.The customer also reported the vessel tortuosity was severe.It is likely the failure to open is the result of vessel tortuosity or re-sheathing the device more than the recommended two times.H6: method code updated to b01.Result code updated to c070601.Conclusion code updated to d15.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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No additional information 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 indicated the patient was being treated for a right, internal carotid artery (ica) aneurysm done via radial access.The pipeline was not in a bend when it failed to open.Resheathing had been performed to reverse the sleeves in an attempt to open the stent, and 30% of the stent had been deployed when it failed to open.The patient did not experience any injury as a result of the event, and the procedure was completed by replacing the devices.
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