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
Positioning Failure (1158); Unintended Movement (3026)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/31/2023 |
Event Type
malfunction
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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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Event Description
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Medtronic received a report regarding a pipeline that moved with deployment and had difficulty positioning.The patient was undergoing surgery for treatment of a fusiform, unruptured aneurysm in the left internal carotid artery (ica) with a max diameter of 18 mm and a 20 mm neck diameter.The landing zone was 3.2 mm distally and 5 mm proximally.It was noted the patient's vessel tortuosity was minimal.Dual antiplatelet treatment was administered.The pru level was 160.The angiographic result post procedure was great.It was reported that giant fusiform left internal carotid aneurysm.Wanted to use a 5 x 35 because proximal landing zone measured a five diameter.The first pipeline was slow and opening and when he went to pull it back, the whole thing dropped and we can advance.We pulled it out and open another 5 x 35. again, the first 5 x 35 with slow and opening.In hindsight, he probably did not go distal enough in the m1 to give it time to open.The second device, which was also a 5 x 35, he went more distal in the m2.Started deploying in the street segment of the m1, and then pull it back and it went much better.It was reported there was movement during placement along with difficult placement/positioning.There were not multiple pipeline devices being used when the movement occurred.There was no friction or difficulty during delivery or positioning.The pipeline was implanted at the intended location.The pipeline did not miss the landing zone.The device did not jump during deployment.The pipeline was placed at least 3mm past the aneurysm neck on each side.There were no branches covered by the pipeline.The tip of the catheter was not moved during deployment.The pipeline was used for an indication that is off-label; specifically "on label." the pipeline and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.
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Event Description
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New information received.The cause of the movement during deployment was not determined.
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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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