MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER
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Model Number PED2-500-14 |
Device Problems
Retraction Problem (1536); Activation, Positioning or Separation Problem (2906); Migration (4003); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/06/2021 |
Event Type
malfunction
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Event Description
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Medtronic received a report that the a balloon was needed to open the pipeline which then moved after it was deployed.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the right ica, posterior communicating artery ( pcom).The max diameter was 7mm, and the neck diameter was 3.5mm.The patient's vessel tortuosity was moderate.The landing zone was 4.75mm distal and 3.8mm proximal. dual antiplatelet medication was administered, and the pru level was 42.It was reported that pipeline was deployed across aneurysm neck without incident.Once deployed the device failed to open at the very proximal end.The proximal end was in a turn.The physician was unable to recapture the delivery wire as the phenom 27 could not get through the proximal end of the deployed device.The delivery wire was removed.The physician attempted to cross the constrained pipeline several times with the microcatheter, guidewire and the guide catheter, all unsuccessfully.Eventually they got a 7mm loop snare inside of the device and opened it enough to get a scepter balloon into the pipeline.While advancing the scepter the proximal end of the pipeline compressed and slid past the aneurysm neck.The device was then open.A second pipeline was placed inside of this pipeline and extended across the neck of the aneurysm, and full wall apposition was achieved.More than 50% of the pipeline had been deployed when it failed to open, and it had been resheathed more than 2 times. the patient did not experience any injury or complications.Angiographic results post procedure showed stasis in the aneurysm and patent flow in the parent vessel.The devices were prepared according to the instructions for use (ifu).Ancillary devices include a.088 80cm ballast sheath, navien guide catheter, synchro guidewire, and phenom 27 microcatheter.
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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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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 that there was no damage observed to the pipeline pushwire or catheter.
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