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Model Number PED-400-25 |
Device Problem
Break (1069)
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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 08/03/2020 |
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 pipeline stent deployed in the microcatheter.The patient was undergoing surgery for intracranial blood flow guided device implantation.It was noted the patient's vessel tortuosity was severe.It was reported that the stent was deployed for the first time, but the position was not ideal.The physician retrieved the stent to redeploy, but the stent became dislodged in the distal segment of the catheter.There was no damage noted to the catheter or pushwire, and a continuous flush had been used.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.Additional information received clarifying that the pipeline separated from the delivery system within the catheter.The pushwire was not rotated or pulled back at any time during the procedure.The device and catheter were removed together and a new catheter and stent were used to complete the procedure.
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Manufacturer Narrative
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The device was not return.H6.Coding updated.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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