MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX WITH SHIELD; INTRACRANIAL ANEURYSM FLOW DIVERTER
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Model Number PED2-450-25 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/17/2020 |
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 after the pipeline was placed, the proximal side of the pushwire was broken when pulled into the phenom microcatheter.The pushwire and microcatheter were successfully retrieved together.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.
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Manufacturer Narrative
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Updated section: a1 to a5: patient information b5: additional information 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 additional information: the treatment location was in the cavernous sinus, lesser curvature side.The aneurysm neck width was 12 mm.The vessel anatomy was tortuous.
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Manufacturer Narrative
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The pushwire appeared to be separated at ~106.6cm from the proximal end with the ptfe shrink tubing broken and stretched at the same location.The separation location was where the proximal corewire met the hypotube.The pushwire was found bent at ~33.2cm and ~81.9cm from the proximal end.The hypotube was found bent at ~29.4cm from the proximal end of the distal segment.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube was found to be intact with no signs of elongation.No defects were found with the tip coil, distal marker, re-sheathing mar ker, re-sheathing pad or with the proximal bumper.No other anomalies were observed.The broken end will be sent out for sem/eds analysis.Based on the returned device, the pipeline flex was confirmed to have pushwire separation issue.Per the sem/eds results: "fatigue features (striations) were observed, indicating the crack initiated via fatigue.The final crack area failed via tensile overload.Lack of fusion is visible at some weld root areas." it is possible that the lack of fusion at some weld area, in addition to reported tortuous patient vessel caused resistance when retracting the pipeline flex w/ shield; subsequently causing the pushwire to separate.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.Review of proximal delivery system subassembly documentation (p/n 50648-001 lot 795521) found no discrepancies for dimension: proximal and distal weld inspection.Certificate of conformance (resonetics) shows tensile strength of wire to hypotube strength between 58.6n to 82.5n, which is within specification (specification >5.0n.The pushwire and hypotube was found bent, indicative of either advancing/retracting the device against resistance or damage during return shipping to medtronic as the device was returned without its protective dispenser coil or introducer sheath.As the microcatheter involved in the event was not returned, any contribution of the phenom -027 micro catheter towards the pushwire separation could not be determined.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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