MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	PED-425-35
Medical Device Problem Codes	Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3.Earliest date of publishing is used for reported event date.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 or Problem Description
Barros, g., <(>&<)> levitt, m.R.(2022).Treatment of an acutely ruptured complex fusiform middle cerebral artery aneurysm with flow diverting stenting and adjunctive coil embolization.Neurosurgical focus: video, 7(2), v5.Https://doi.Org/10.3171/2022.7.Focvid2249.Medtronic review the online video and literature transcript found information regarding a 27-year-old female patient who underwent p rocedure to treat an acutely ruptured large, complex left fusiform middle cerebral artery (mca) with flow diversion and adjunctive coiling via right radial access.A 072 navien intracranial support catheter was used as well as phenom plus guide catheter for additional support.A phenom 27 microcatheter was used for pipeline deployment and an echelon 10 microcatheter was positioned in the aneurysm dome for jailing and partial coiling of the aneurysm.A pipeline flex 4.25 x 35mm stent was deployed first from the superior m2 to the distal m1 segment, partially spanning the aneurysm dome and jailing the inferior division m2.Because the proximal end of the stent did not adequately cover the entire aneurysm, the phenom 27 microcatheter was navigated through the implanted pipeline and a second pipeline flex 4.25 x 25mm was implanted telescoping from the largest portion of the aneurysm dome to the distal carotid terminus.The phenom 27 was then pulled back through the pipeline construct and computed tomography (ct) showed good proximal and distal wall apposition with completed aneurysm coverage achieved.The patient was administered a half-loading done of eptifibatide intra-a rterially via the navien catheter a prophylactic antiplatelet effect.Two non-medtronic coils were then deployed through the jailed echelon 10 microcatheter into what was considered the ruptured point of the aneurysm.Loose coiling of the aneurysm was intentional to prevent significant thrombosis of the perforator vessels.The system was removed and post-procedure angiography showed reduced intra-aneurysm flow with contrast stasis.Follow-up angiograms at 4 days, 4 weeks, and 6 months post-operative showed aneurysm reduction and mca remodeling with no significant vessel branch obstruction/occlusion.It was additionally noted that the patient failed wean from her external ventricular drain and underwent an additional procedure for placement of a ventriculoperitoneal shunt for long-term hydrocephalus management which was performed by general surgery.The patient continued on dual antiplatelet treatment (dapt) for 6 months post index procedure; ticagrelor was then discontinued and the patient continued on aspirin 81mn daily for long-term.Additional information received reported that there was no relationship between any medtronic device used in the index procedure with any adverse event reported in the article.Additional information received from med safety indicating as a drain was required for hydrocephalus prior to the procedure, the event of permanent drain required was not attributed to the procedure or the medtronic devices used in the procedure.
Additional 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.
Event or Problem Description
Additional information received reported that the second device was always planned given the size and complexity of the aneurysm.

• Brand Name: PIPELINE FLEX
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17833218
• Report Number: 2029214-2023-01887
• Device Sequence Number: 3278710
• Product Code: OUT
• UDI-Device Identifier: 00847536016293
• UDI-Public: 00847536016293
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2022
• Device Model Number: PED-425-35
• Device Catalogue Number: PED-425-35
• Device Lot Number: A848751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 10/24/2023
• Date Device Manufactured: 06/15/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 90 KG