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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER
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| Model Number PED2-500-30 |
| Device Problems
Break (1069); Physical Resistance/Sticking (4012)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 12/07/2022 |
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Event Type
malfunction
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Event Description
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Medtronic received information that a ped2 pipeline pushwire broke in the proximal section.Pushwire was damaged during advancing the delivery system.The broken segment of pusher wire was out of the patient.There was severe friction and difficulty during delivery.The devices were prepared as indicated in the instructions for use (ifu).The patient was being treated for an unruptured, amorphous aneurysm in the internal carotid artery (ica).The max diameter was 15.94mm and the neck diameter was 7mm.The distal landing zone was 3.9mm and the proximal landing zone was 4.48mm.Vessel tortuosity was severe.Angiographic result post procedure was good.No patient symptoms or complications were reported. ancillary devices: sofia 6f 115 guide catheter, phenom 27 160cm microcatheter, synchro 14 guidewire, optima8mm-10mm coils.
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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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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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New information received.The model/lot # of phenom catheter was au21-050.Resistance occurred in the ica siphon.There was damage to the pipeline pushwire and/or catheter.It was separated.
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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 reported the pushwire separated.Resistance occured in the distal section of the catheter.
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Manufacturer Narrative
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H3: product analysis of ped2-500-30, lot# b271534 as found condition: the pipeline flex w/ shield device and phenom-27 micro catheter were returned for analysis within a shipping box and within a sealed tyvek biohazard pouch.The distal pipeline flex w/ shield pusher and braid were returned within the phenom-27 hub and proximal micro catheter lumen.Visual inspection/damage location details: no flash or voids molded were found within the phenom-27 micro catheter hub.Dried saline was found within the hub.No damages or anomalies were found with the hub.The micro catheter body was found flattened and twisted between ~43.5cm and ~51.0cm from the proximal end and found flattened/twisted at ~3.2cm from the distal end.No damages or irregularities were found with the distal tip or marker band.No damages were found with the pipeline flex w/ shield proximal pusher.The hypotube was found stretched with the ptfe shrink tubing undamaged.No damages were found with the proximal bumper, resheathing pad or pad restraints.The distal dps restraint was found damaged.The dps sleeves and proximal restraint were found intact with no signs of damage.The tip coil was found to have separated from the distal delivery wire.The distal delivery wire was found kinked.Each braid ends of the micro catheter were found fully opened, damaged, frayed, and covered in partially dried blood.The phenom-27 micro catheter total length was measured to be ~157.9cm and the usable length was measured to be ~151.1cm, which is within specification (specification: total (ref) = 156.5cm; usable = 150cm ± 5cm).The pipeline flex w/ shield could not be retracted or advanced out of the micro catheter as it was found stuck.The micro catheter was cut, and the hub was destroyed to remove the distal pusher and braid.The inner diameter was measured to be 0.027¿ at the distal end, which is within specification (specification: 0.027¿ ± 0.001¿) and compatible for use with the pipeline flex w/ shield device.The proximal inner diameter could not be measured as it was destroyed during the extraction of the pipeline flex device.In-house resistance testing of the device could not be performed as the micro catheter was destroyed.Conclusion: based on the analysis findings, the customer report of ¿pushwire break/separation¿ at the proximal segment could not be confirmed as the pusher was returned intact.The customer report of ¿catheter resistance¿, and ¿resistance during delivery¿ was confirmed as resistance was found with the returned pipeline flex w/ shield device within the phenom-27 catheter.In addition, the damages found (hypotube stretch, pad restraint damage, braid damaged, tip coil separation, and micro catheter damages) are consistent with resistance.Possible causes for resistance are damaged catheter, damage to pipeline/pushwire, patient vessel tortuosity, user does not maintain continuous flush, or user pulls back on /torques wire while advancing ped in micro catheter.Customer reported devise were prepared per ifu and vessel tortuosity as severe.It is likely the severe patient tortuosity contributed towards the resistance.The micro catheter was found twisted and flattened.Potential causes are patient vessel tortuosity, delivery system removed aggressively, catheter entrapment or user advances/retrieves the device against resistance.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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