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

Model Number	PED-425-12
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a pipeline that failed to open in the middle.The patient was undergoing a procedure for flow diverter treatment of an unruptured saccular aneurysm in the right internal carotid artery (ica) ophthalmic segment.The aneurysm max diameter was 2.5mm and the neck diameter was 2.2mm.Vessel tortuosity was moderate.Dual antiplatelet treatment (dapt) was administered with pru level 58.It was reported the pipeline and all accessory devices were prepared as indicated in the instructions for use (ifu).The pipeline was delivered but failed to open in the middle section.The device was resheathed several times (more than 2) but still would not open completely.It was noted that the middle of the pipeline was positioned in a vessel bend.More than 50% of the pipeline was deployed when the failure to open occurred.A clot formed on the stent.Aggrestat and tissue plasminogen activator (tpa) were administered intra-artery and redeployment was attempted but the clot formed again so the pipeline was resheathed and removed with the microcatheter.
Event or Problem Description
Additional information received reported that the procedure was not completed.At this time, there was not a procedure plan change as well as there was no additional intervention for treatment of the patient's aneurysm planned for the future.The patient was currently asymptomatic.
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.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.
Additional Manufacturer Narrative
H3: the phenom-27 micro catheter was found kinked at ~2.5cm from the distal end.The pipeline flex was found within the phenom-27 catheter.The distal braid was found damaged.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.

• 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
• MDR Report Key: 11931902
• Report Number: 2029214-2021-00659
• Device Sequence Number: 19932386
• Product Code: OUT
• UDI-Device Identifier: 00847536016088
• UDI-Public: 00847536016088
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2021

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: 11/09/2023
• Device Model Number: PED-425-12
• Device Catalogue Number: PED-425-12
• Device Lot Number: B115262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 06/03/2021; 07/30/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 06/24/2021; 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 72