MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER
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Model Number PED2-475-25 |
Device Problems
Positioning Failure (1158); Material Deformation (2976); Unintended Movement (3026); Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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It was reported the physician information could not be provided due to restriction by privacy regulations.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 after accessing the segment distal to the aneurysm with the phenom 27 microcatheter, the pipeline was deployed in the middle cerebral artery (mca).Re-sheathing was performed, but it was found the distal end of the stent was damaged and deployment could not be performed.An attempt to deploy the stent with the pushwire was done several times, but eventually the stent was collected because the stent was damaged and could not be opened.Re-sheathing was performed three or more times, less than 5% of the stent had been deployed when it failed to open, and the stent was not positioned in a bend.Both the phenom 27 and pipeline were replaced with new products to complete the procedure.It was indicated that all devices were prepared/hydrated as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Ancillary devices include a launcher 8fr guiding catheter, chikai 14 guidewire, pipeline, transform 4x7.
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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 there was existing severe stenosis at the distal end of the aneurysm, which was only about 50% of the planned landing vessel diameter.The stenosis made it very difficult to make a landing at the distal.The first pipeline was noted to be resheathed at least 15 times.There was no friction felt at the time of the delivery.At the time of positioning, the tip was unfolded, an anchor was applied, and the stent was not opened at the point where it exceeded the flexion.The pipeline did not jump during deployment.The tip of the catheter was not moved during deployment.Patient vessel tortuosity was noted to be severe with about 180 degree bend on the outflow side of the aneurysm.
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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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This information was previously reported in manufacturer report # 2029214-2021-00531.Additional information indicated that these events are duplicates.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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Medtronic received a report that the pipeline failed to open and there was difficulty during deployment.The patient was undergoing treatment for a cavernous aneurysm with a maximum diameter of 13mm.The distal vessel diameter was 4.8mm, and the proximal vessel diameter was 4.9mm.It was reported that when the sleeve of pipeline was removed on the middle cerebral artery the deployment was poor.However, the mic rocatheter was dropped on the internal carotid artery without any actions, and the deployment was started. the distal end of the stent opened in the landing zone on the distal side, but the stent did not open at all beyond the tortuous part. after that, when wire pushing and resheathing were performed several times to open the stent, it was confirmed that the tip coil of pipeline did not move even when the wire was pushed and pulled, and the behavior seemed to deviate from the wire. before the tip coil distally migrated, slowly cover the tip coil with phenom 27, and removed the device together with the phenom27 without any actions.The phenom 27 and pipeline were replaced. the event was said to be not associated with a patient. the devices were prepared and hydrated according to the instructions for use (ifu).Ancillary devices include a launcher 8fr guide catheter, phenom 27 microcatheter, and chikai 14 guidewire.
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Manufacturer Narrative
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H3: no damages or irregularities were found with the phenom-27 catheter hub, catheter body, distal tip and marker band.The pipeline flex w/ shield device was found within the phenom-27 catheter.The distal braid and distal wire were found already deployed out of the catheter tip.The pipeline flex was then fully deployed, and the pusher was retracted out against resistance.Dried blood was found within the phenom-27 micro catheter and on the pipeline flex w/ shield pusher and braid.The hypotube was found unstretched and undamaged with the ptfe shrink tubing still intact.No damages were found with the distal marker, re-sheathing marker or with the proximal bumper.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The tip coil was found intact.The proximal braid did not fully open as it was found occluded with dried blood.The distal braid was found partially opened.The dried blood was dissolved, and the proximal braid fully opened, while the distal braid still failed to fully open.Both braid ends were found frayed and damaged.Based on the analysis findings, the customer report of ¿failure/incomplete open distal (flex)¿ was confirmed.Possible causes are patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid was overstretched during delivery, user deploys braid in vessel braid, presence of other indwelling stents or inappropriate anatomy.Customer report of ¿pipeline damaged during delivery/retrieval¿ was confirmed.Possible causes are resheathing more than 2 times, high force delivery, over-manipulation, delivering/retracting delivery wire against resistance, or deploying/resheathing braid against resistance.Customer reported device was not placed in a bend, less than 5% was deployed, pipeline was resheathed 3 or more times and patient vessel tortuosity as severe.It is possible the coagulated blood contributed towards the failure to open.The customer report of ¿difficult placement/positioning¿ could not be confirmed through device analysis.Possible causes are patient vessel tortuosity, braid incorrectly sized to vessel, resistance, other indwelling stents, braid damaged, braid deployed in vessel bend, micro catheter tip not correctly placed or braid not anchored correctly.There is no indication that the event is related to a potential manufacturing issue.There was no damages or irregularities found with the phenom-27 that would contribute towards the incomplete open or difficult positioning.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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