MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER
|
Back to Search Results |
|
Model Number PED3-027-450-14 |
Device Problems
Activation, Positioning or Separation Problem (2906); Activation Failure (3270); Physical Resistance/Sticking (4012)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/03/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Medtronic received a report that the pipeline failed to open in the mid and distal section during deployment.The physician attempted to re-advance with challenge through the microcatheter, after which it re-opened more in the distal end.A balloon was then used to attempt to open it more, but the distal end was not well apposed to the artery wall.As a result another pipeline was used which did not open rapidly in the mid part, but did open successfully and the final result was sufficient.The patient was undergoing recanalization of an unruptured ica aneurysm of unknown dimensions.It was noted that the patient's vessel tortuosity was moderate.More than 50% of the pipeline was deployed when it failed to open, and more than 2 resheathing attempts were made.There were no related patient symptoms.Dual antiplatelet treatment was administered and the pru level was as usual.Post procedure angiographic results were good.The devices were prepared as indicated per the ifu.
|
|
Event Description
|
Additional information received indicated the pipeline had been placed in a curve when it failed to open.
|
|
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.
|
|
Event Description
|
Medtronic received report regarding 2 pipeline vantage devices which required assistance of a balloon as well as implantation of an additional pipeline to optimize wall apposition.It was unknown if there was any impact to the patient.However, it was noted that no additional medical intervention was required to prevent permanent injury or impairment.Additional information received reported the first pipeline was accused of not achieving wall apposition and after the balloon also failed to achieve wall apposition.A second pipeline was deployed to optimize wall apposition.Wall apposition was achieved at the end of procedure.It was stated that there was no device deficiency.The patient was undergoing treatment for a single previously ruptured and coiled saccular right ica c6 sidewall saccular aneurysm which was 6.2mm x 2.8mm with 3.7mm neck size.
|
|
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.
|
|
Event Description
|
Additional information received reported that per (b)(6) image read of the 12m dsa on (b)(6) 2023, raymond &roy (r & r) occlusion was class 2, noting 'better'.Previous (b)(6) r(&)r assessments: index treatment dsa ((b)(6) 2021) - class 3; 6m dsa ((b)(6) 2022) - class 3, noting 'better'.Site has reported no symptoms, nor actions taken.
|
|
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.
|
|
Search Alerts/Recalls
|
|
|