|
Model Number PED-475-30 |
Device Problems
Unintended Movement (3026); Physical Resistance/Sticking (4012)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/08/2022 |
Event Type
malfunction
|
Event Description
|
Medtronic received information that a ped pipeline failed to open and was kinked.Another moved during placement.A marksman catheter had resistance and was accordioned.The patient had multiple aneurysms in the posterior communicating segment of the left ophthalmic artery, and was ready for flow diversion therapy.Established the access, after microcatheter marksman was in place, selected the ped-450-35 stent, after high pressure normal hydration, it was delivered in place.After tried for a long time in the m1 segment, the tip of the stent was abnormal and could not be opened.Pulled back to the inner segment of the neck still could not be opened.After withdrawing from the body, it was found that the tip of the stent was kinked.The surgeon believed that this was a product quality problem, a new stent ped-475-30 was required to be replaced.The surgeon reported that the marksman delivered normally during this process, there was no blocking feeling when pushing the stent in vitro and in vivo.Therefore, it was believed that the marksman could still be used normally, and the new catheter had not been replaced.During the delivery of ped-475-30 in place, the feedback delivery was also smooth, it also opened normally in the m1 segment.After re-recovered 5mm stent, it was pulled to the neck to locate.When it was pulled back into the neck, due to the large curvature of the m1 segment, so the stent bounced and slid down, deviation from the distal anchor point.The surgeon wanted to re-recover the stent and reposition it.When retracting the stent, the surgeon reported that the resistance was large.After imaging, it was found that the stent guide wire was recovered, but the stent was not recovered successfully.After the whole system was withdrawn from the body, it was found that the microcatheter had shown an accordion phenomenon.The stent could not be recovered in vitro.After repeated attempts, it still could not be recovered.Therefore, the stent could only be pushed out.Re-replaced the microcatheter phenom27 and ped-475-35, and the surgery was completed.The devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed as per (ifu).The patient was getting treatment of aneurysm flow with dense mesh stent.Vessel tortuosity was minimal.The access vessel was the femoral artery with a diameter of 5.2mm.No patient symptoms or complications were reported.Ancillary devices: 8f short sheath, 8fguiding guide catheter, marksman microcatheter, navien 5f microcatheter.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Additional information received reported the ped device bounced when pulling back the internal carotid artery, no bounce during deployment of the internal carotid artery.The catheter tip was not moved during ped deployment.The tip end was not opened, and one side of the tip end was in the shape of a bell mouth.The distal stent tried to push out a length of 20mm, but it still did not open, and the stent was rod-shaped as a whole.Tried to open the pipeline at the unbent position of m1 horizontal segment, and then pulled to the unbent position of internal carotid artery segment, and it was attempted to open, but it could not be opened.No addition steps were attempted to open the device.
|
|
Manufacturer Narrative
|
Product analysis: as found condition: the pipeline flex device was returned for analysis within a shipping box; within a plastic bio-pouch; and within a dispenser coil.Visual inspection/damage location details: 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 and ptfe shrink tubing were found to be intact with no signs of elongation.No bend was observed on the pushwire.The distal and proximal ends of the pipeline flex were found fully opened and moderately frayed.No defects were found with the tip coil, distal marker, re-sheathing marker, pads or with the proximal bumper.No other anomalies were observed.Testing/analysis: none.Conclusion: based on the analysis findings, the pipeline flex was not confirmed to have movement during delivery and resistance.The event cause could not be determined.No damages found with the returned pusher.The distal and proximal ends of the pipeline flex braid were found fully opened and moderately 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.There was no non-conformance to specifications identified that led to the reported issues.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.
|
|
Search Alerts/Recalls
|
|
|