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Model Number NV UNK PIPELINE |
Device Problems
Material Deformation (2976); Appropriate Term/Code Not Available (3191); Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/12/2022 |
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 during the process of the marksman deploying the pipeline, the tip was kinked and damaged and the stent could not be deployed effectively.After replacement, the stent was deployed successfully.The catheter was flushed as indicated in the ifu.The devices were prepared as indicated in the ifu.There were no patient symptoms or complications associated with the event.The patient was undergoing treatment of an aneurysm.The vessel tortuosity was minimal.Additional information was received indicating the model of the pipeline was a 4.5-25.The reason for the stent not being able to be deployed was due to the blood vessel being somewhat twisted and tip being unable to be opened.The device was adjusted several times, they pushed and pulled the marksman back and forth, however the effect of the deployment was not good.The in-vitro examination found an organ-like kink at the tip.
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Manufacturer Narrative
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A4.Patient weight (60kg).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 distal segment of the pipeline opened poorly.The distal patient vessel was relatively straight but the proximal vessel was tortuous.About 3 attempts were made to deploy the pipeline but then it was noted that the catheter was kinked so the devices were removed.There were no additional steps or devices attempted to open the pipeline.
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Manufacturer Narrative
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Additional information received provided no indication that the device would be returned.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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Search Alerts/Recalls
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