Model Number PED2-350-25 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Rupture (2208); Obstruction/Occlusion (2422)
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Event Date 01/05/2022 |
Event Type
Death
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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 information that two pipeline flex shields were used without issue and follow up imaging confirmed excellent placement and apposition.As the system was removed after deployment it appeared that the stress on the vessel caused the vessel to re-rupture.After the aneurysm ruptured the entire right side of the anterior circulation shut down.The patient is deceased.The patient was being treated for a ruptured fusiform aneurysm in the right a2 location.The max diameter was 2mm and the neck diameter was 20mm.The distal landing zone was 2.6mm and the proximal landing zone was 2.8mm.Vessel tortuosity was minimal.The pipeline was used for a indication that was not approved: a2.The devices were prepared according to the instruction for use (ifu).Angiographic result post procedure; both aca and mca were completely clotted.
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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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Additional information received reported the physician isn't certain on what caused the bleed but he does feel that the ptfe sleeves may have caused the vessel to tear at the uncovered vessel.No medical events or procedures lead up to patient's death.The patient was hospitalized prior to passing.The patient presented to the er with bad headaches and ct scan discovered giant, fusiform partially thrombosed a2 aneurysm.
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Event Description
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Additional information received reported the aneurysm ruptured in the anterior cerebral artery a2 segment.The patient had presented with and unruptured, partially thrombosed aneurysm.Dual antiplatelet treatment (dapt) was administered.
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Manufacturer Narrative
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Associated with rr #: (b)(4).B5.Updated with additional information received.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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