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Model Number PED-400-20 |
Device Problems
Unintended Movement (3026); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/22/2021 |
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 pipeline moved during deployment.The patient was undergoing treatment for an unruptured, fusiform aneurysm located in the right posterior communicating artery.The max diameter was 6mm.The patient's vessel tortuosity was moderate.The landing zone was 2.2mm distal and 3.9mm proximal. dual antiplatelet treatment was administered, and the pru level was 83.It was reported that the pipeline slid back short of intended landing zone.The physician attempted to recapture the device but could not.The pipeline was removed and replaced.There had not been any friction or difficulty during delivery or positioning, and multiple pipeline devices were not being used at the time.The corking technique was used to remove the pipeline, but no additional devices were used to remove the it.It was noted that the pipeline had jumped during deployment.The pipeline had been placed at least 3mm past the aneurysm neck on each side, and no side branches were covered by the device.The tip of the catheter had been moved during deployment. angiographic results post procedure showed stasis in the aneurysm and a patent parent vessel. the patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).Ancillary devices include a ballast 80cm sheath, phenom plus guide catheter, phenom 27 microcatheter, and synchro 2 standard guidewire.
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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 the catheter was flushed continuously during the procedure.There was no damage observed to the pipeline pushwire.
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Search Alerts/Recalls
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