Medtronic received a report that the stent could not be opened normally.When the device was recovered into the microcatheter, it was determined the tip end of the stent was deformed.There were no symptoms or complications associated with the event.It was unknown if the dapt (dual antiplatelet treatment) was administered.The angiographic post-procedure showed contract agent had retention.The pipeline was not used off-label and the pipeline was prepared as indicated in the ifu.The pipeline failed to open distally.The pipeline was not positioned in a bend.More than 50% of the pipeline had been deployed when it failed to open.The pipeline was resheathed less than or equal to 2 times.There were no additional steps required to open the pipeline.The pipeline was removed with a snare/retrieval device.The patient was undergoing surgery for treatment of a fusiform, unruptured aneurysm with a max diameter of 23mm and a 12mm neck diameter.It was noted the patient's blood flow was vessel tortuosity was minimal.
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Associated with rr #: 2029214-2022-00028.The event is reported at this time based on analysis results which indicated a reportable event.Product analysis: equipment used: video inspection system (m-78210), ruler 200cm (m-83361), camera (panasonic lumix dmc-zs5) and 0.0265¿ mandrel.As found condition: the pipeline flex embolization device and marksman catheter were returned for analysis within shipping box; and within a plastic bio-pouch.The pipeline flex pushwire was returned partially outside the marksman catheter.In addition, tip coil, sleeves and distal hypotube were deployed from marksman distal tip.Visual inspection/damage location details: the total and usable lengths of the catheter were measured and not be within specifications.The catheter appeared to be cut at the distal end ~120.5cm from the hub and not returned for analysis.Therefore, any contributing factors could not be assessed.No bent or kink were found with catheter body.No flash or voids molded were observed in the hub.No other anomalies were observed.Testing/analysis: for further examination, the pipeline flex was pushed out from the catheter with difficulty.Catheter was flushed with water and water exited out from the distal tip.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub, lumen and tip with no issues.However, the resistance observed at the damaged locations.There was no braid inside the catheter.Conclusion.Based on the analysis findings, it is most likely the catheter was cut intentionally.There was no complaint made by the customer against the marksman microcatheter.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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