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

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Stenosis (2263)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

The pipeline devices will not be returned for evaluation as they remain implanted in the patient.Based on the reported information, there does not appear to have been any defect of the device during use.The event occurred in the patient post-procedure and its cause could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.

Event Description

2019-11-26, e1, hcp: wang, t., zhang, c.W., richard, s.A., chaohua, w., <(>&<)> xie, x.D.(2019).Reactive in-stent stenosis of a pipeline embolization device in a child.Medicine, 98(47).Doi: 10.1097/md.0000000000018092.Medtronic literature review found a report of in-stent stenosis after pipeline implantation.The patient presented with a right cavernous segment giant aneurysm and underwent endovascular treatment.During the procedure, one pipeline device was placed successfully.During the attempt of a second pipeline, the first pipeline was noticed to have displaced into the aneurysm sac.The aneurysmal artery was able to be reconstructed with three pipeline devices.The patient was discharged home.The six-month follow-up revealed a smaller aneurysm sac and a further decrease in blood flow.The ipsilateral anterior cerebral artery (aca) opacification was no longer visible.It was observed that the vertebral artery and contralateral aca compensated the right middle communicating artery (mca) and right aca through the posterior communicating artery (pca).In-stent stenosis at bridging points of the pipeline devices was also observed.The patient underwent retreatment in which stents were implanted in the stenotic point.The blood flow and speed improved and the ipsilateral aca was visible again.

Manufacturer Narrative

A4: weight.Additional information b5: event description.Additional information g4: date manufacturer received.Additional information g7: type of report.Additional information h2: follow-up type.Additional information h10: additional manufacturer narrative.Additional information, device evaluation.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 Description

Additional information was received: the pipeline flex that foreshortened was ped-375-35, lot: a569565.Afterward, three pipeline fle x devices (ped-400-35/a588065, ped-475-35/a569088, ped-500-30/a568385) were implanted.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9492611
• MDR Text Key: 172818287
• Report Number: 2029214-2019-01264
• 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,l
• Type of Report: Initial,Followup
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR
• Patient Weight: 40