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

Model Number PED-400-14

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 05/02/2019

Event Type  Injury  

Manufacturer Narrative

As the device was still in use at the time this investigation was completed, no analysis could be performed.There was no indication that the event was related to a potential manufacturing issue and no dhr was requested, so a device history record review was not performed.Based on the reported information, the exact cause for the reported event is unknown but rather a procedure related event.The device will not be returned for evaluation as it was implanted in the patient.The dimensions of the aneurysm were not provided; so analysis on the choice of sizing of the pipeline could not be made.Per the instructions for use (ifu): choose a pipeline¿ flex embolization device with labeled diameter that approximates the target vessel diameter.Select an appropriately sized pipeline¿ flex embolization device such that its fully expanded diameter is equivalent to that of the largest target vessel.An incorrectly sized pipeline¿ flex embolization device may result in inadequate device placement, incomplete opening, or migration.The pipeline¿ flex embolization device foreshortens substantially (50-60%) during deployment.Take device foreshortening into account when deploying the pipeline¿ flex embolization device.Choose a pipeline¿ flex embolization device with labeled length that is at least 6 mm longer than the aneurysm neck.Contraindications: the pipeline¿ flex embolization device should not be used alone as sole therapy for acutely ruptured aneurysms.The investigation determined that this was a known event, and therefore no new formal investigation was required.Common sequences of events and contributing factors that can lead to this known event are documented in the risk management file.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that a residual aneurysm (raymond and roy class 3) was noted on dsa imaging and the medtronic flow diverter was noticed to have foreshortened and no longer completely covered the neck of the aneurysm during the 180 day follow up visit.The patient has not stopped taking p2y12 inhibitor.No treatment was given, but site states that they will retreat to fully cover aneurysm.Date of future treatment was not provided.

Event Description

Medtronic received information that the patient underwent re-treatment with a pipeline flex with shield.

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.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.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9691062
• MDR Text Key: 178533231
• Report Number: 2029214-2020-00132
• 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: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2020
• Device Model Number: PED-400-14
• Device Catalogue Number: PED-400-14
• Device Lot Number: A556727
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 02/10/2020
• Supplement Dates Manufacturer Received: 02/18/2020
• Supplement Dates FDA Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 49 YR