MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER
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Model Number PED2-500-18 |
Device Problems
Positioning Failure (1158); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/16/2023 |
Event Type
malfunction
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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.
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Event Description
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Medtronic received a report that a pipeline encountered resistance during resheathing. the patient was undergoing surgery for treatment of an amorphous, unruptured aneurysm in the right ica with a max diameter of 9 mm and a 5 mm neck diameter.The landing zone was 5 mm distally and 5 mm proximally.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet treatment was administered.The pru level is unknown.The angiographic result post procedure showed the pipeline device was explanted and fred device was subsequently implanted successfully.Device was well apposed, covering the neck of the aneurysm and contrast stagnation was noted within the dome and body of the aneurysm consistent with successful flow diversion.It was reported that the patient was getting a tcar procedure for narrowed carotid artery and simultaneous pipeline through direct access to embolize ica aneurysm.The md was trying to partially resheath after the device was about 80% deployed but noted he had no more one to one control of the device.The pusher wire was inside the pipeline, but still looked constrained by the microcatheter.He was able to bring up the intermediate and successfully retrieve device and explant it.Subsequently, finished the case with a fred flow diverter (5x14-21). the pipeline was used for an indication that is off-label.The patient was getting a tcar procedure for narrowed carotid artery and simultaneous pipeline through direct access to embolize the ica aneurysm.The pipeline and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.Ancillary devices include a pneumbra benchmark 071 95cm guide catheter, headway27 microcatheter, aristotle014 guidewire.
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Event Description
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Additional information was received that the physician was unable to resheath in order to reposition the device after deploying nearly 80%.Attempts to place the pipeline stent failed due to detachment of the pusherwire from the stent.The detachment did not allow for complete detachment of the pipeline device.It opened just fine otherwise but the physician lost control in the sense that the pusher wire wasn't one to one.The pusher wire was inside the proximal end of the device but the braid was still constrained.Rather than completing the deployment, the physician was able to bring up the intermediate catheter and recaptured everything as a system.The device was retrieved and removed from the body.
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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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