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Model Number PED-425-30 |
Device Problems
Unintended Ejection (1234); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/13/2021 |
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 stent could not push out the catheter during delivery and was detached from the phenom catheter during the pushing process.There was resistance in the distal end of the catheter.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the left ophthalmic artery segment with a max diameter of 19mm and a 10mm neck diameter.It was noted the patient's vessel tortuosity was normal.It was reported that the stent could not push out the catheter during delivery and was detached from the phenom catheter during the pushing process.There was resistance in the distal end of the catheter.The catheter was flushed continuously with heparanized saline.Thepipeline was not stuck.The catheter and pushwire were not damaged.There were no patient symptoms or complications associated with this event.It was unknown whether a dapt (dual antiplatelet treatment) was administered.The angiographic results post procedure were fine.The pipeline was not used for an indication that was not approved (off-label).The pipeline and accessory devices were prepared as indicated in the ifu.Ancillary devices include a 5f intermediate catheter navien.
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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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Manufacturer Narrative
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H3: the distal and proximal ends of the braid were found fully opened and slightly damaged.No other anomalies were observed.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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