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

Model Number PED2-450-20

Device Problems Activation, Positioning or Separation Problem (2906); Migration (4003)

Patient Problem Embolus (1830)

Event Date 07/26/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the first pipeline deployed foreshortened unpredictably, requiring a second pipeline to be deployed across the first and stabilize the proximal landing zone.The overlapping/telescoped ends of the pipeline separated such that both were protruding into the aneurysm toward the fundus, so a third pipeline was required to bridge the gap across the fundus of the aneurysm rather than in the parent artery.Within 24 hours of procedure the patient had distal embolic events in both the pipeline territory as well as adjacent territories.No evidence of thrombus in the device was seen at this stage.Follow up 10 weeks later showed a filling defect in device construct in the mca with loss of ipsilateral a1.Instent stenosis was >50% in the most distal device, aneurysm was sufficiently shut down.The patient was put on heparin infusion for 5 days and the physician is to follow up.Angioplasty is to be required.The patient was undergoing surgery for treatment of an unruptured, amorphous aneurysm.Dual antiplatelet treatment was administered, the pru level was unknown.Post procedure angiographic results showed haemodynamic stasis in the aneurysm and the parent artery was fully patent.The devices were prepared as indicated per the ifu.It was noted that the patient's vessel tortuosity was normal.

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

There was no resistance felt, no damage to the pushwire or catheter.

• 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: 8847026
• MDR Text Key: 152905979
• Report Number: 2029214-2019-00801
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-450-20
• Device Catalogue Number: PED2-450-20
• Device Lot Number: A737772
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/26/2019
• Initial Date FDA Received: 07/31/2019
• Supplement Dates Manufacturer Received: 08/12/2019
• Supplement Dates FDA Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR