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Model Number PED-450-14 |
Device Problems
Material Deformation (2976); Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/29/2021 |
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 report that the first pipeline (model: ped-450-14, lot: b082276) was delivered but failed to open at the distal end when more than 50% deployed.The pipeline was resheathed 2 or less times.No other techniques or devices were tried to open the pipeline.The physician attempted to resheath the pipeline to remove but the ptfe sleeve seemed to be stuck on the phenom 27 microcatheter so the microcatheter and pipeline were both removed together and replaced.An attempt was then made to implant a pipeline (model: ped-450-18, lot: b084497).During advancement through the internal carotid artery (ica), the phenom 27 microcatheter jumped back.It was thought this may possibly have been due to lack of sufficient support from the intermediate catheter.The pipeline failed to open when less than 50% was deployed.The pipeline was resheathed 2 or less times. no other techniques or devices were tried to open the pipeline.The pipeline was not positioned in a vessel bend.The pipeline was resheathed and removed.A pipeline (model ped-450-12) was then used and opened successfully but was too short and did not cover the aneurysm neck.A fourth pipeline (model: ped-475-14, lot: b031754) was then tried but would not open distally within the already implanted ped-450-12.The ped-475-14 was less than 50% deployed when the failure to open occurred.The pipeline was resheathed more than 2 times without opening successfully. no other techniques or devices were tried to open the pipeline.It was resheathed and removed with the microcatheter.The patient was undergoing a flow diverter implantation procedure to treat an unruptured saccular aneurysm in theleft internal carotid artery (ica).The aneurysm max diameter was 3mm and the neck diameter was 2mm.Vessel tortuosity was moderate.Post-procedure angiography showed the single pipeline was deployed.The patient had no related symptoms or complications.
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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.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 was received on (b)(6) 2021.It was reported that the doctor does not recall the tip of the catheter being under stress when the catheter jumped.No additional pipeline or other treatment has been administered to address the incomplete neck coverage, and none is planned at this time.No procedural / post-procedural imaging (ct,angio, etc.) are available.
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Manufacturer Narrative
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H3.Product analysis: the pipeline flex was returned stuck within the phenom 27 catheter and outer carton; inside of a sealed bio-hazard bag and a shipping box.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 appeared to be stretched with the ptfe shrink tubing still intact.The distal and proximal ends of the pipeline flex braid were found fully opened and frayed.Bends were found at 16.0cm to 47cm from the proximal end.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The total and usable lengths of the catheter were measured to be within specifications.The catheter tip and marker were examined; no damages were found.The catheter body appeared to be accordioned at 8.0cm to 23cm from the distal tip.No flash or voids molded were observed in the hub.The pipeline flex was pushed out from the catheter lumen with difficulty.The catheter was flushed with water and water e xited out from the distal tip.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub with no issues; however, resistance was observed at the damaged locations.No other anomalies were observed.Based on the returned devices, the pipeline flex was confirmed to have ¿resistance during resheathing¿ and "pipeline damage" issues as the returned pipeline flex was found stuck inside the phenom catheter.However, the pipeline flex was not confirmed to have "failure to open at the distal end" as the distal and proximal ends of the braid were found fully opened and frayed.The damage to the braid on the ends of the pipeline flex is likely the results of the physician re-sheathing the device more than recommended two times.From the damages seen on the catheter (accordioning), pusher (bending), pipeline flex braid (fraying) and hypotube (stretching); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance/retrieve the pipeline flex through the phenom catheter against the resistance.Possible cause includes patient tortuous anatomy.There was no non-conformance to specifications identified that led to the resistance issue.Per our instructions for use (ifu), the user should: ¿begin to deliver the device using a combination of unsheathing the pipeline flex embolization device and pus hing delivery wire simultaneously.After the distal end of the pipeline flex has successfully expanded, deploy the remainder of the device.The system is designed to allow for 2 full cycles of re-sheathing of the pipeline flex embolization device.Re-sheathing the pipeline flex embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid.Discontinue delivery of the device if high force or excessive friction is encountered during delivery.Identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ 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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