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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER
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| Model Number PED2-450-25 |
| Device Problems
Break (1069); Activation Failure (3270)
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| Patient Problem
Device Embedded In Tissue or Plaque (3165)
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| Event Date 12/29/2020 |
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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 a report that the pipeline failed to open in the distal segment.The patient was undergoing treatment for an unruptured, saccular aneurysm.The max diameter was 5.8mm, and the neck diameter was 3.2mm.The vessel tortuosity was normal.The landing zone was 4.0mm distal and 4.6mm proximal.It was reported that the distal part of the device would not open despite manipulation.The stent was resheathed 4 times in first de livery.Less than 50% of the pipeline had been deployed when it failed to open, and no other steps were taken to open the device.The physician decided to remove the device and pulled back the delivery wire to the proximal ica.They changed their decision and pushed the same device again to the desired location.After the second unsheath they realized that the coil tip remained in the vessel.The pipeline was removed with the microcatheter, but the distal coil remained in the patient.The patient status was said to be alive with no injury, symptoms, or other complications.The devices were prepared according to the instructions for use (ifu).Ancillary devices include a marksman microcatheter.
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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 indicated the tip of the wire was located to a branch on the internal carotid artery (ica) and the p hysician was not concerned about any complications at the time of the report.
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Event Description
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The pipeline was not placed in a bend.
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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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Additional information received reported clarification that the the pipeline was deployed 4 times and resheathed a total of 5 times.
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Event Description
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No additional information received.
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Manufacturer Narrative
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H3: analysis of the pipeline flex shield braid (lot no.B039993) found that the distal and proximal ends of the pipeline flex shield appeared to be opened and moderately frayed.No other anomalies were observed.Based on the returned device, the pipeline flex shield was not confirmed to have "failure to open at the distal" and "pushwire separation" issues as the pipeline flex shield was returned without the pushwire.The root cause could not be determined as the distal and proximal ends of pipeline flex shield braid were opened and moderately frayed.The damage to the braid on the ends of the pipeline flex shield braid is likely the results of the physician re-sheathing the device more than recommended two times.Possible cause of failure to open includes vessel tortuosity.There was no non-conformance to specifications identified that led to the failure to open issue.Since the pushwire was not returned; any contribution of the pushwire to the separation issue could not be determined.H6: method code updated to b19.Result code updated to c070601.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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