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Medtronic received information regarding a pipeline pushwire that broke.The patient underwent a procedure for flow diverter implantation to treat an unruptured saccular aneurysm of the right paraophthalmic artery segment.The aneurysm max diameter was 9mm and the neck diameter was 4mm.Vessel tortuosity was moderate.Dual antiplatelet treatment (dapt) was administered.It was reported that the pipeline and all accessory devices were prepared as indicated in the instructions for use (ifu).After the pipeline was deployed, the phenom 27 catheter could not go through the device to retrieve the delivery wire so the wire was pulled back through the pipeline and collected into the phenom catheter and removed from the patient.Afterwards, the distal tip of the pushwire was found detached on the work table area.No broken segments were left within the patient.It was noted that there had been moderate difficulty opening the distal end of the pipeline.However, post-procedure angiography showed good results. there were no patient symptoms or complications associated with this event.
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Product analysis: the pipeline flex pushwire was returned for evaluation inside of a sealed biohazard bag and shipping box.There was no pipeline flex shield braid returned with the pushwire.The distal and proximal dps restraints were found intact.The dps sleeves were found intact with no signs of damage.The distal hypotube appeared to be stretched.In addition, the pipeline flex pushwire appeared to be detached at the hypotube proximal to the wire weld.No defects were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.The end of the detached pushwire was sent out for sem/eds analysis.Based on the analysis findings and sem/eds analyses, the pipeline flex was confirmed to have "pushwire separation" as the returned pushwire appeared to be detached at hypotube proximal to the wire weld.In addition, the pushwire hypotube was also found to be stretched.The distal wire of the pipeline flex delivery system was possibly detached due to the solder tensile failure.A review of the manufacturing process did not uncover any deficiencies with regard to the soldering process.Proper soldering technique and surface preparation (tinning) were well defined and documented appropriately in the associated manufacturing procedures.In addition, the elemental analysis conducted through scanning electron micrographic (sem) / energy dispersive spectroscopy (eds) showed presence of soldering material (ti n); thereby indicating that the soldering was conducted.The proof load of 2.5n performed on 100% of the devices (section starting with hypotube solder to distal pad solder joint).There was no non-conformance to specification that lead to the resistance and detac hment issues.Furthermore, the review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.Per our instructions for use (ifu): "discontinue delivery of the device if high force or excessive friction is encountered.Identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ h6.Coding updated based on analysis results.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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