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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER
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| Model Number PED2-450-14 |
| Device Problems
Positioning Failure (1158); Unintended Movement (3026)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 03/07/2022 |
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Event Type
malfunction
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Event Description
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Medtronic received information that one ped2 pipeline failed to open and two pipelines had movement during deployment and had difficult placement and positioning.The patient was being treated for an unruptured carotid siphon aneurysm.Vessel tortuosity was severe.The devices were prepared according to the instructions for use (ifu). pipeline 4.25x14 and 4.5x14 were not deployed because the system kept falling down after the initial deployment.Multiple pipelines were not being used when the movement occurred.There was no friction or difficulty during delivery or positioning.The pipeline was not implanted at the intended location.No additional steps were taken.The pipelines missed the landing zone.The device did not jump during deployment.The pipeline was placed at least 3mm past the aneurysm neck on each side.The tip of the catheter moved during the deployment.The procedure was successful and stent was deployed, stagnation was observed during the angiogram (post procedure).No symptoms were reported. ancillary devices: navien guide catheter, phenom27 lot ap21-053 microcatheter, phenom 27 lot ju21-035 microcatheter, sheath.
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Manufacturer Narrative
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Event related to reports 2029214-2022-00427 and 2029214-2022-00426.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 dual antiplatelet therapy was administered.For the first pipeline, close to 75% had been deployed when it failed to open.Just proximal to the point of no resheathing.The device was resheathed into the microcatheter.However, the microcatheter had fallen back and needed to be navigated distally which was not possible by itself with the ped within it.This would require a microcatheter and microwire.Therefore, attempted to remove the ped out of the microcatheter and of the body.However, it could not be captured into the introducer sheath.The ophthalmic side branch was covered.Not from movement of the device.
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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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Product analysis: ¿ as found condition: the pipeline flex embolization device and phenom 27 catheter was returned for analysis within a shipping box.The pipeline flex embolization device was returned within an opened pipeline flex outer carton (b117706) and within an opened pipeline flex inner pouch (b117706).The phenom 27 catheter was returned within an opened phenom 27 outer carton (ap21-053) and within an opened phenom 27 outer carton (ap21-053).¿ visual inspection/damage location details: the pipeline flex pusher distal hypotube was found stretched with the shrink tubing pulled back from the proximal bumper.The pusher distal core wire was found broken proximal to the sleeves.The pipeline flex braid was found stuck within the phenom 27 catheter hub.The phenom 27 catheter hub, catheter body, and distal tip were found in good condition.The phenom 27 catheter was dissected (cut) and the broken pipeline flex distal segment with braid were removed.The pipeline flex pusher sleeves and tip coil were found damaged.The pipeline flex braid proximal and distal ends were found damaged (frayed).¿ testing/analysis: the phenom 27 catheter total length was measured to be ~159.0cm and the useable length was measured to be ~152.4cm which is within specification (specification: 150cm ± 5cm).The broken pipeline flex distal core wire was sent out for sem (scanning electron micrographic) failure analysis.Per the analysis report, the wire failed via torsional overload ¿ conclusion: based on the device analysis and reported information, the customer¿s ¿difficult placement/positioning¿ and ¿movement during deployment¿ reports could not be confirmed.Difficult placement/positioning and movement during deployment can be caused by vasospasm, patient vessel tortuosity, high force delivery, catheter kickback, microcatheter tip not correctly placed, insufficient distal anchoring of braid, braid deployed in vessel bend, or incorrect braid sizing.In this event, it is likely the catheter kickback and the patient¿s ¿severe¿ vessel tortuosity contributed to the events.No defect was found with the phenom 27 catheter that would have contributed to the events.Regarding the damages found with the pipeline flex pusher (stretching/separation) it appears force was used.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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