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| Model Number PED-425-25 |
| Device Problems
Material Deformation (2976); Activation Failure (3270); Physical Resistance/Sticking (4012)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 05/13/2021 |
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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 information regarding a pipeline that failed to open at the distal end and was found damaged after resistance during delivery in the marksman microcatheter.The patient was undergoing a procedure for flow diversion treatment of an unruptured saccular aneurysm of a posterior communicating artery.The aneurysm max diameter was 4.3mm and the neck diameter was 3mm.The distal landing zone was 3.25mm and the proximal 4.11mm.Vessel tortuosity was moderate.It was reported that all devices were prepared and the catheter flushed continuously with heparinized saline as indicated in the instructions for use (ifu).The transition was not smooth when the pipeline was first inserted in the marksman microcatheter and there was resistance during delivery.When the marksman catheter reached the distal end of the artery, the pipeline was delivered and the catheter retrieved but it was found that the pipeline distal tip could not be opened.After repeated attempts, the stent still could not be opened.The pipeline was resheathed and the pipeline and marksman catheter were withdrawn together as a whole.Once outside of the patient's body, the tip of the pipeline was found to be damaged and appeared abnormal.It was also noted that the distal end of the pushwire was kinked.Both the pipeline and the marksman catheter were replaced an the replacement pipeline was successfully implanted.There was no harm or injury to the patient.
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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 the pipeline was not placed in a vessel bend when it failed to open.The doctor increased tension once in order to attempt to open the pipeline.It was noted that there was damage to the marksman catheter.
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Event Description
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Additional information received reported it was suspected there was internal damage to the catheter due to being unable to deliver the pipeline.
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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 #(b)(4):equipment used: video inspection system (m-78210), ruler (m-83361), pin gauge sets (m-84083, m-84081), camera (panasonic lumix dmc-zs5), 0.0260¿ mandrel drawing(s) referenced: fa-55xxx-xxxx rev.P; dwgsped-xxx-xx rev.H as found condition: the pipeline flex device and marksman micro catheter were returned for analysis within shipping box; within individual sealed plastic biohazard pouches and within their respective dispenser coils.The pipeline flex braid was already deployed and returned within the same biohazard pouch.Visual inspection/damage location details: no damages or irregularities were found with the marksman catheter hub.The marksman micro catheter body found kinked at ~61.3cm and ~72.4cm from the proximal end and kinked between ~11.3cm and ~6.9cm from the distal end.The marksman micro catheter was found accordioned between ~28.9cm and ~24.1cm from the distal end.The marksman catheter tip pebax outer layer was found peeled back.The pipeline flex hypotube was found unstretched and undamaged with the ptfe shrink tubing still intact.The distal delivery wire was found kinked near the resheathing pad.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.Both braid ends were found frayed and damaged.The middle braid was found damaged.The braid was found flattened throughout the braid.Testing/analysis: the marksman micro catheter total length was measured to be ~158.8 and the usable length was measured to be ~151.3cm; which is within specification (specification: total (ref) = 157cm ± 3cm; usable = 150cm ± 3cm).The inner diameter of the marksman micro catheter was measured to be 0.0260¿ at the hub and 0.0270¿ at the distal end, which is within specification (specification: 0.027¿ ± 0.001¿).An in-house mandrel was inserted into the hub, through the micro catheter and became stuck at ~72.5cm from the proximal end.Conclusion: based on the analysis findings, the customer report of ¿failure/incomplete open distal (flex)¿ could not be 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.The braid was found damaged.Potential causes for braid damage are resheathing more than 2 times, high force delivery, over-manipulation, delivering/retracting delivery wire against resistance, deploying/resheathing braid against resistance, or damage during return shipping as the braids were returned already deployed and out of its protective introducer sheath and dispenser coil.Customer reported all devices were prepared per ifu, patient vessel tortuosity as moderate, continuous flush was used, and device was not positioned in a bend.The marksman micro catheter was confirmed to ¿catheter kink/damage¿.The catheter was found kinked/accordioned and the distal tip outer pebax layer was found peeled back.Possible causes are patient vessel tortuosity, user advance/retrieve device against resistance, device removed aggressively, or catheter entrapment.The customer report of ¿resistance in catheter hub¿ could not be confirmed, however the customer report of ¿resistance/stuck during delivery¿ and ¿pipeline damaged during delivery/retrieval¿ was confirmed.From the damages seen on the catheter body (accordioned/kinked), pipeline distal pusher (kink) and braid (frayed/damaged); it appears there was high force used.It is possible these damages occurred when the customer attempted to advance/retrieve the pipeline flex through the marksman catheter against resistance.Possible contributors towards the failure are patient vessel tortuosity or lack of continuous flush.There is no indication that the event is related to a potential manufacturing issue.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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