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

Model Number PED-400-20

Device Problem Activation Failure (3270)

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

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that the pipeline flex was advanced into the intended location, however, the pipeline was unable to open at the distal section.The devices were prepared and used per the instructions for use (ifu).A continuous flush was used.The pipeline was less than 50% deployed when it failed to open.The device was resheathed less than 2 times.The anatomy was moderate.No patient injury occurred.There was no damage noticed to the devices.This event occurred during the treatment of an unruptured, saccular, aneurysm.The max diameter was 6.5x 54mm and the neck was 6mm.The distal landing zone was 3.98mm and the proximal was 3.84mm.

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 braid returned separate within folded gauze.The pipeline flex pushwire returned within medtronic catheter.The pipeline flex pushwire was pulled out from within the catheter with slight resistance.No bend was found on the pushwire.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.No damages were found with the proximal bumper, re-sheathing pad, re-sheathing marker, or distal marker.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The tip coil outer coils were found stretched with the core wire intact.The distal and proximal ends of the pipeline flex braid appeared to be fully opened and slightly damaged (frayed).No other anomalies were observed.Based on the returned device analysis and reported information, we were unable to determined that cause of the failure to open during the procedure.Possible contributing factor of failure to open includes patient severe vessel tortuosity.However, the patient¿s vessel tortuosity was ¿moderate¿.The damage to the braid on the ends of the pipeline flex is likely the results of re-sheathing the device more than recommended two times.From the damages seen on pipeline flex braid (fraying); it appears there was high force used.Damage is likely to occur if the pipeline flex is advance through the catheter against resistance.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: 9336301
• MDR Text Key: 186750963
• Report Number: 2029214-2019-01139
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536015937
• UDI-Public: 00847536015937
• 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: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2022
• Device Model Number: PED-400-20
• Device Lot Number: A867840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR