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

Model Number	PED-475-30
Medical Device Problem Codes	Positioning Failure (1158); Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not received.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 or Problem Description
Medtronic received information that a pipeline flex device did not open during a procedure.The patient underwent embolization treatment of unruptured, saccular right internal carotid artery supraclinoid giant wide neck aneurysm, measuring 24mmx7mm.Landing zone distal 3.2mm, proximal 5.3mm.The vessel was observed severely tortuous.It was reported that after getting into the m1 segment, physician exposed the device.Initially the ptfe sleeves did not open up but after few maneuvers he was able to open the ptfe sleeves and the distal part of the device.Continued to deploy the device.While deploying the device at the neck of the aneurysm, the device did not open up.Re-sheath the device and deployed it again still the device was not opened.After lot of maneuvers device did not opened up.He decided to take out the device.While taking out the device from the micro catheter device got deployed at the hub of micro catheter.Ped was replaced by another flow diverter of different manufacturer and the procedure was completed uneventfully.There were not any patient symptoms or complications associated with this event.There were not any images available for review.The patient¿s blood flow was normal.The vessel was normal.No patient injury was reported.Reported device and any accessory devices were prepared as indicated in the ifu.The pipeline was not positioned in a bend.Less than 50% of the pipeline had been deployed when it failed to open.Less than or equal to 2 times the pipeline was re-sheathed.There were not any additional steps or other devices required to open the pipeline.The pipeline resheathed and removed with the headway 27 microcatheter.A continuous flush was used during the case.
Additional 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.The pipeline flex braid was returned detached from the pushwire; therefore, the distal and proximal ends of the braid were unable to be identified.Both ends of the pipeline flex braid were found fully opened and moderately frayed.No bend found on the pusher.No damages were found with the tip coil, distal and proximal dps restraints and sleeves, re-sheathing marker, resheathing pad and proximal bumper.The distal hypotube appears to be slightly stretched with the ptfe shrink tubing intact.Based on the retuned device analysis and reported information.We were unable to determined the cause of " failure to open" issue during the procedure.The event cause could not be determined as the distal and proximal ends of the pipeline flex braid was found fully opened but moderately frayed.The damage to the pipeline flex braid ends and the stretched distal hypotube are likely the result of the physician re-sheathing the device more than recommended two times.In addition, the customer reported that the patient¿s vessel tortuosity was severe.It¿s possible that the ¿severe vessel tortuosity¿ may have contributed to the reported issues.Per our instructions for use (ifu): "begin to deliver the device using a combination of unsheathing the pipeline flex embolization device and pushing delivery wire simultaneously.After the distal end of the pipeline flex has successfully expanded, deploy the remainder of the device.Carefully inspect the deployed pipeline flex 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.Re-sheathing the pipeline flex 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
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9162093
• Report Number: 2029214-2019-00989
• Device Sequence Number: 2308254
• Product Code: OUT
• UDI-Device Identifier: 00847536016804
• UDI-Public: 00847536016804
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/03/2021
• Device Model Number: PED-475-30
• Device Lot Number: A718154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1