Model Number PED3-027-450-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 07/13/2021 |
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 the patient complained of pain in the right lower abdomen.A post-procedure computerized tomography (ct) performed (b)(6) 2021 showed retroperitoneal bleeding, and the patient hemoglobin (hgb) dropped to a low value of 6.22.The event resulted in a prolongation of hospitalization and required a blood transfusion.It was assessed the event was not related to the underlying condition, antiplatelet medication, or study device; the event was related to the study ancillary device and probably related to the procedure.The patient was undergoing surgery for treatment of a saccular aneurysm of the left internal carotid artery (ica) c5 with a max diameter of 6.6 mm and a 6 mm neck diameter.
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Manufacturer Narrative
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B5.Updated with additional information received.D4.Device model and lot number updated.Mdr decision corrected to not reportable - there was no reported malfunction of the device which is not marketed in the us.No further reports will be submitted unless additional information received indicates a reportable event.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 that the patient complained of pain in the right lower abdomen.A post-procedure computerized tomography (ct) performed (b)(6) 2021 showed retroperitoneal bleeding, and the patient hemoglobin (hgb) dropped to a low value of 6.22.The event resulted in a prolongation of hospitalization and required a blood transfusion.It was assessed the event was not related to the underlying condition, antiplatelet medication, or study device; the event was related to the study ancillary device and probably related to the procedure.The patient was undergoing surgery for treatment of a saccular aneurysm of the left internal carotid artery (ica) c5 with a max diameter of 6.6 mm and a 6 mm neck diameter.Additional information received reported the patient was recovering and the event resolving.The patient was discharged on (b)(6) 2021.Device model and lot received and updated.Mdr decision corrected to not reportable - there was no reported malfunction of the device which is not marketed in the us.No further reports will be submitted unless additional information received indicates a reportable event.
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Event Description
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Additional information received reported post implant - indicate aneurysm occlusion (raymond and roy) at the end of the procedure: class 3.
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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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