|
Model Number PED-425-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Death (1802); Intracranial Hemorrhage (1891)
|
Event Date 08/09/2020 |
Event Type
Death
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Medtronic received a report that prior to deploying 3 pipeline devices, 2 other pipeline were attempted to be deployed but encountered a lot of resistance and had to be withdrawn.The devices were replaced with larger sizes.Giant aneurysm was noted as an incidental finding.The patient was treated successfully with the devices, but experienced a perforator stroke 24 hours post procedure, followed by a hemorrhage and death.The devices were prepared per the ifu.The patient was undergoing treatment of an unruptured, saccular left mca aneurysm with a max diameter of 15mm and a neck diameter of 8mm.Ancillary devices include a benchmark guide catheter, phenom 27 microcatheter, synchro 14 guidewire.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Additional information received reporting that the patient died on (b)(6) 2020 and it was stated to be related to the patient's disease condition.
|
|
Search Alerts/Recalls
|
|
|