MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER
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Model Number PED2-450-35 |
Device Problems
Activation Failure (3270); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/27/2021 |
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 a report that the distal part of the pipeline failed to open and became stuck in the distal part of the phenom microcatheter.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the supraclinoid segment of the left ica.The max diameter was 12mm, and the neck diameter was 8mm.The patient's vessel tortuosity was severe.The landing zone was 3.9mm distal and 4.4mm proximal.The access vessel was the left ica which was 4.4mm in diameter.It was reported that the delivery catheter was parked distally, and when the pipeline was unsheathed distally and while passing neck of the aneurysm the device failed to take proper wall apposition.Resheathing was done and another attempt was made, but in the following attempt device was not taking wall apposition at all.Resistance was observed in the delivery catheter while unsheathing it again.It was observed that the device was stuck in catheter distally.The pipeline was not placed in a bend, and less than 50% had been deployed when it failed to open.The pipeline had been resheathed more than 2 times, and no additional steps or other devices were used to open the device.The pipeline and catheter were removed from the patient and replaced. angiographic results post procedure showed low flow rate in the aneurysm. the patient did not experience any injury or complications.The devices were prepared and flushed according to the instructions for use (ifu).
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Manufacturer Narrative
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G3: pma/510(k) corrected.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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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 there was no damage observed to the pipeline pushwire.
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Search Alerts/Recalls
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