MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER
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Model Number PED2-425-16 |
Device Problems
Break (1069); Unintended Ejection (1234); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/10/2021 |
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 information regarding a pipeline that was stuck at the distal end of the catheter and deployed in the catheter.The patient was undergoing a procedure for flow diverter treatment of an unruptured saccular aneurysm of an internal carotid artery (ica) siphon.The aneurysm max diameter was 3.5mm and the neck diameter was 1.9mm.Vessel tortuosity was normal.Dual antiplatelet treatment (dapt) was administered with pru level of 200.It was reported that all devices were prepared according to the instructions for use (ifu).The pipeline became stuck at the distal part of the microcatheter and could not be pushed out.The physician pulled the pushwire to attempt to retrieve the pipeline but the pipeline was deployed within the catheter and only the pushwire came out.It was noted that the catheter was flushed continuously with heparinized saline per ifu.There was no damage to the catheter or the pipeline pushwire.Both devices were replaced to complete the procedure.There was no harm or injury to the patient.Post-procedure angiography revealed good results.
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Event Description
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Mdr decision corrected to not reportable.No additional supplemental reports are required unless additional information received indicates reportable event.
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Manufacturer Narrative
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Review of this mdr received shows there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury.There this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.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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H10: previous report submitted in error.Event did not and does not meet the reporting requirements stipulated in 21 cfr 803.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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H3: analysis of the pipeline flex shield (lot no.B129907) found that the distal and proximal dps restraints were 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 shield braid were found fully opened and moderately frayed.Bends were found at 21.0 cm to 27.0 cm 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 20.0 cm to 30.5 cm from the distal tip.No flash or voids molded were observed in the hub.The pipeline flex shield could not be pushed forward or removed.For further examination, the marksman catheter was cut to remove the pipeline flex shield.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 shield and marksman catheter were confirmed to have ¿resistance during delivery¿ and ¿catheter resistance¿ issues as the returned pipeline flex shield was found stuck inside the distal segment of the marksman catheter.From the damages seen on the catheter (accordioning), pusher (bending), pipeline flex shield braid (fraying) and hypotube (stretching); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance the pipeline flex shield through the marksman catheter against the resistance.However, the root cause could not be determined.Possible causes of the resistance during delivery include patient's vessel tortuosity and lack of continuous flush with heparinized saline during procedure.There was no non-conformance to specifications identified that led to the resistance issue.H6: method code updated to b01.Result code updated to c070601 and c0702.Conclusion code updated to d15.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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