MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER
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Model Number PED2-500-12 |
Device Problems
Material Deformation (2976); Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/07/2022 |
Event Type
malfunction
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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, saccular aneurysm in the ophthalmic artery.The max diameter was 2mm, and the neck diameter was 1.5mm.The patient's vessel tortuosity was moderate.The landing zone was 6mm distal and 7mm proximal. dual antiplatelet treatment was administered, and the pru level was 55.It was reported that the physician was deploying the pipeline in the terminus area of the patient.The device failed to open distally after three attempts to re-sheath and looked crimped at the distal end.The pipeline was not positioned in a bend and more than 50% of it had been deployed when it failed to open.No additional steps were taken to open the device. the pipeline was replaced, and the patient did not experience any injury or complications.Angiographic results post procedure showed successful deployment of the second device.The devices were prepared according to the instructions for use (ifu).
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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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Product analysis: ¿ as found condition: the pipeline flex embolization device was returned for analysis within a shipping box, within a plastic bio-pouch, and within a secondary plastic bag.¿ visual inspection/damage location details: the pipeline flex pusher was found ¿wavy¿ from ~71.0cm to ~22.0cm from the proximal bumper.The shrink tubing was found pulled back from the proximal bumper.The pusher resheathing pad, sleeves, and tip coil were found in good condition.The braid was returned already detached from the pusher.Therefore, the proximal and distal ends could not be identified.The braid ends were found damaged (frayed).The braid middle segment was also found damaged.¿ testing/analysis: none ¿ conclusion: based on the device analysis and reported information, the customer¿s ¿failure/incomplete open distal¿ report could not be confirmed as the device has been fully deployed and re-sheathed.Regarding the customer¿s ¿pipeline damaged¿ report the issue was confirmed.It is possible the damage found with the pipeline flex braid or the patient¿s ¿moderate¿ vessel tortuosity contributed to the event.Damage to the pipeline flex embolization device (wavy pusher/braid damage) can occur if the device is advanced/retrieved against resistance.However, the cause for the damages could not be determined.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 were no other procedural issue noted that may have caused damage to the pipeline.The cause of the pipeline failure to open was undetermined.
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Search Alerts/Recalls
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