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

Model Number PED-500-20

Device Problems Activation Failure (3270); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex with shield has been returned for evaluation.A follow-up mdr will be submitted when the investigation is complete.The device involved in this event is not approved in the us; the device's brand name and model number are provided below.This report is being filed against a similar device, which is provided.Brand name: pipeline flex with shield technology, model number: ped2-500-20.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information this pipeline flex with shield device did not open during the procedure.The patient was undergoing embolization treatment for a small unruptured saccular right internal carotid artery, measuring 2.5cm.Landing zone distal 3.75mm proximal 4.9mm.The vessel was observed severely tortuous.The pipeline and any accessory devices were prepared as indicated in the ifu.It was reported that during the procedure, the pipeline device was not able to be opened.The device was removed.On removal, the device became stuck in the microcatheter hub.There were no reports of patient injury.

Manufacturer Narrative

D10: device available for evaluation - additional information g4.Date mfr rec ¿ additional information h2: type of follow up - device evaluation h3: device evaluated by manufacturer- additional information h6: codes updated the device was returned for evaluation and the clinical observation could not be confirmed.As received, the pipeline flex with shield device delivery system was returned without the braid.No bends or kinks were found with the pipeline flex pushwire.The hypotube was found to be intact with no elongation of the ptfe.The distal portion of the pipeline flex delivery system was found to be intact with no damage (proximal pad restraint, re-sheathing pad, re-sheathing marker, dps sleeves and tip coil).Without returned the pipeline flex with shield device braid, we were unable to confirmed the report of failure to open during the procedure and cause could not be determined.It was reported that patient anatomy was observed severely tortuous.It is possible that failure to open is the result of vessel tortuosity or re-sheathing the device more than the recommended two times.Per our instructions for use (ifu), the user should: ¿begin to deliver the device using a combination of unsheathing the pipeline flex with shield embolization device and pushing delivery wire simultaneously.After the distal end of the pipeline flex with shield has successfully expanded, deploy the remainder of the device.Carefully inspect the deployed pipeline flex with shield embolization device under fluoroscopy to confirm that it is completely apposed to the vessel wall and not kinked.If the device is not fully apposed or is kinked, consider using a balloon catheter, micro catheter, or guide-wire to fully open it.The system is designed to allow for 2 full cycles of re-sheathing of the pipeline flex with shield embolization device.Re-sheathing the pipeline flex with shield embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ 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 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: 9351845
• MDR Text Key: 186752409
• Report Number: 2029214-2019-01149
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2021
• Device Model Number: PED-500-20
• Device Lot Number: A702322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR