MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER
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Model Number PED2-500-35 |
Device Problems
Break (1069); Material Deformation (2976); Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/26/2021 |
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 a report that the tip of the pipeline would not open and the pushwire fractured during removal.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the right ica.The max diameter was 13mm, and the neck diameter was 6mm.The patient¿s vessel tortuosity was moderate.The landing zone was 5mm distal and 5mm proximal.Dual antiplatelet treatment was administered.It was reported that when the pipeline was deployed the tip became entangled and did not open easily.Pushing and resheathing were a ttempted for a while, but it did not open, and the device had to be collected.The physician wanted to keep the catheter inside, so only the pipeline was pulled.When pulling it out, the implant device did not come out and only the pushwire was removed so the phenom 27 was cut.The guide wire was delivered from there and the catheter was pulled out.The tip coil of the pushwire fractured and was found in the navien at that time.Recovery was attempted several times.The physician eventually used suction to recover the tip coil.The physician continued the procedure along the wire leaving the phenom27, and a new pipeline was implanted.It was confirmed from the recovered device that there were no fragments in the bodythat had been separated into the pushwire, protective sleeve, and tip part.The patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).Ancillary devices include a navien 058 catheter, 8f gc guide catheter, and phenom 27 microcatheter.
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Manufacturer Narrative
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H3: analysis of the pipeline flex (lot no.B088642) found that the pipeline flex pushwire appeared to be separated proximal to the dps sleeves.The tip coil, dps restraints, sleeves and catheter were not returned.The reason for not returning was not provided.The distal hypotube found 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.No bend was found on the pushwire.No damages were found with the distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.No other anomalies were observed.The broken end sent out for sem analysis.Based on the analysis findings and sem analysis, the pipeline flex shield was confirmed to have "pushwire separation" issue as the pipeline flex pushwire was found to be separated proximal to the dps sleeves.The fracture surface exhibits dimple features consistent with torsional overload failure mechanism.In addition, from the damage seen on the hypotube (stretching); it appears there was high force used.It is likely these damage occurred when the customer attempted to deliver the pipeline flex through the phenom catheter against resistance.Regarding the "failure to open" issue, the customer complaint could not be confirmed as the distal and proximal ends of the pipeline flex shield braid were found fully opened and moderately frayed.The damage to the braid on the ends of the pipeline is likely the results of the physician re-sheathing the device more than recommended two times.It is likely that the patient tortuous anatomy may have contributed the failure to open and pushwire separation issues.There was no non-conformance to specifications identified that led to the failure to open and pushwire separation issues.H6: method code updated to b19.Result code updated to c070601 and c070603.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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Event Description
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Additional information received from a manufacturing representative (rep) indicated the pipeline was not placed in a bend: an attempt was made to deploy the stent in a part that would not normally be a problem, various measures were tried but it didn't open.
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Search Alerts/Recalls
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