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Model Number PED-500-14 |
Device Problem
Activation Failure (3270)
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Patient Problem
Fistula (1862)
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Event Date 06/16/2021 |
Event Type
Injury
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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 3 pipeline devices were lazy to open in the middle and distal segments and were recapture multiple times which did not resolve the issue.The devices were removed and subsequent devices used.The fourth device was used successfully but was also a bit lazy to open, and the proximal end was not completely opposed.After multiple attempts to cross into the device, it was found that a small fistula had formed, so another pipeline was used to cover the fistula which was implanted successfully and provided a satisfactory result.The patient was undergoing an unruptured, saccular aneurysm with a max diameter of 6mm and a neck width of 4mm.The devices were prepared as indicated per the ifu and the patient's vessel tortuosity was noted to be severe.The devices were placed in a bend in the middle section during deployment.Dual antiplatelet treatment was administered, the pru level was unknown.Post procedure angiographic results showed partial filling of the aneurysm.
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Event Description
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Additional information received report pipelines were re-sheathed multiple times without success to open the devices fully.No balloons were used.
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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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Search Alerts/Recalls
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