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Model Number PED-475-25 |
Device Problem
Activation Failure (3270)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/09/2020 |
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 segment of the pipeline failed to open.The tip of the stent was repeatedly pushed and pulled, but still could not be opened.It was noted the stent was not positioned in a bend, more than 50% of the stent was deployed, re-sheathing was performed more than twice, and no additional steps or devices were used in an attempt to open the pipeline.A replacement stent was used to complete the procedure.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Post-procedure angiography showed slowed blood flow.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the cavernous sinus with a max diameter of 5.87 mm and a 4.9 mm neck diameter.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was ad ministered, and the platelet reactivity units (pru) level was up to standard.Medical history includes: hypertension, hyperglycemia (diabetes) and hyperlipidemia.
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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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The pushwire was found to be kinked at 143.7cm from proximal end.The hypotube was found to be intact and the ptfe pulled back.The proximal bumper, re-sheathing marker and re-sheathing pad were found to be intact.The dps sleeves were found to be intact.The tip coil was found to be damaged.Due to the condition in which the braid was returned the distal and proximal ends could not be determined.Both ends of the pipeline flex braid were found fully collapsed and frayed.No other damages or anomalies were found with the device.Based on the device analysis and reported information, the customer¿s report of ¿failure/incomplete open distal¿ was confirmed as both ends of the pipeline flex braid were found to be collapsed and frayed.The customer reported having re-sheathed the device more than 2 times.The customer also reported the vessel tortuosity was moderate.It is likely the failure to open is the result of vessel tortuosity or re-sheathing the device more than the recommended two times.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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