MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; LASER THERAPY PRODUCT
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Model Number PED2-400-20 |
Device Problem
Activation Failure (3270)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/07/2020 |
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 did not open in the distal segment during treatment of a cerebral aneurysm.Several maneuvers were performed to open it without success.The stent was retracted, and a second stent was used successfully to complete the procedure.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms, or further complications were reported as a result of this event.
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Event Description
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Additional information received reported that this was not a tortuous case, and the doctor noted that it was quite favorable.There no additional steps performed for stent implantation.
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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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H3: the pipeline flex embolization device (model: ped2-400-20 lot: a873189) and marksman catheter (model: fa-55150-1030 lot: 217934251) were returned for analysis.The pipeline flex with shield was returned inside the marksman catheter and the tip coil, sleeves, pads and distal hypotube were deployed from marksman distal tip.The pipeline flex with shield was pushed forward from marksman catheter without any issues.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 with shield braid appeared to be fully opened and slightly frayed.No damages were found with the 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 band were examined; and no damages were found.The catheter body was found to be accordioned from ~24.8cm to ~31.2cm from distal tip.No flash or voids molded were observed in the hub.Based on the returned device, the pipeline flex shield was not confirmed to have failure to open at the distal end as the distal and proximal ends of the pipeline flex shield braid were found fully opened and slightly frayed.However, the cause for damage could not be determined.There was no non-conformance to specification identified that led to the failure to open issue.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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