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

Model Number PED2-475-30

Device Problem Activation Failure (3270)

Patient Problem Headache (1880)

Event Date 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

Since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.No corrective action.Monitoring and trending this type of event.Linked with mdrs: 2029214-2020-00565, 2029214-2020-00659.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the first pipeline was implanted without issue, but did not completely bridge the aneurysm.A second pipeline of the same size was then used, but it did not open and had to be removed.A third stent was implanted to completely bridged the aneurysm.Construction still appeared unstable and was not completely opened proximally.An eclipse double-lumen balloon was used for follow-up dilation, after which another pipeline stent was implanted.The balloon was used again to further dilate the stents.The three stents concluded with very good results and clear stasis in the aneurysm.There was strong and more prompt perfusion of the intracranial vessels.Post the intervention, the patient reported a headache and was given medication.

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 updated the adverse event term to ¿cephalagia generalized¿ and assessed the event to have a ¿causal relationship¿ to study procedure and ¿possible¿ relationship to the study device.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10240488
• MDR Text Key: 199888998
• Report Number: 2029214-2020-00660
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 08/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2021
• Device Model Number: PED2-475-30
• Device Catalogue Number: PED2-475-30
• Device Lot Number: A643855
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR