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

Model Number	PED2-475-16
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding 2 pipeline flex with shield stents that failed to open at the distal end.The patient was undergoing a procedure for flow diverter treatment of an unruptured 6mm saccular aneurysm of the left internal carotid artery (ica) terminus.The distal landing zone was 2.06mm and the proximal landing zone was 4.75mm.Vessel tortuosity was normal.It was reported the pipelines are all accessory devices were prepared as indicated in the instructions for use (ifu).The first pipeline (model: ped2-475-14, lot: b284830) was taken up to the m1 segment of the middle cerebral artery (mca) to deploy and drag back.Upon deployment, the distal end of the pipeline failed to open.The physician attempted 3 times to resheath and deploy the device without successful opening of the pipeline.Less than 50% of the pipeline had been deployed when the failure to open occurred.The pipeline was resheathed more than 2 times.The pipeline was not positioned in a bend.There were no other steps or devices tried to open the pipeline.The pipeline was resheathed and removed with the microcatheter.A second pipeline (model: ped2-475-16, lot: b271888) was then used and taken to the m1 segment of the mca to deploy and drag back.Upon deployment, the distal end of the pipeline failed to open.The physician tried to resheath and unsheath 3 times without success in opening the device.The device was unsheathed vs.Pushed when deployed. less than 50% of the pipeline had been deployed when the failure to open occurred.The pipeline was resheathed more than 2 times.The pipeline was not positioned in a bend.There were no other steps or devices tried to open the pipeline.It was noted that the physician was instructed to push more wire but the tip coil of the device stayed stagnant.The pipeline was resheathed and removed with the microcatheter.A competitor's device was used to successfully complete the procedure.There was no harm or injury to the patient.Post-procedure angiography results were find and showed everything was normal after use of the competitor's device.Ancillary devices: phenom 27 microcatheter (model: fg15160-0615-1s, lot: 221577785), phenom 27 microcatheter (model: fg15160-0615, lot: 221943671), catalyst 5 115cm guide catheter, infinity sheath, synchro standard guidewire.
Additional Manufacturer Narrative
H3: two pipeline flex w/ shield braids and two unknown phenom-27 micro catheters were returned for analysis within a shipping box; within a sealed tyvek biohazard pouch and within two sealed plastic biohazard pouches.The pipeline flex w/ shield pushers used during the event were not returned for analysis.It is not possible to determine which device belonged to which pli and all four will be addressed together.Visual inspection/damage location details: (braid 1) both ends of the braid were found fully opened, frayed, and damaged.No other anomalies were observed.(braid 2) both ends of the braid were found fully opened, frayed, and damaged.No other anomalies were observed.(phenom-27 1) no damages or irregularities were found with the phenom-27 micro catheter hub, catheter body, marker band or distal tip.(phenom-27 2) the phenom-27 micro catheter hub was found scratched on the exterior.The inner lumen of the hub was found undamaged.Dried blood was found within the hub.No damages or irregularities were found with the micro catheter body, marker band or distal tip.Testing/analysis: (phenom-27 1) the phenom-27 micro catheter total length was measured to be ~158.7cm and the usable length was measured to be ~152.1cm.As the model and lot numbers were not reported, compatibility to specification could not be confirmed.The micro catheter was flushed, and water exit the distal end.A 0.0265¿ mandrel was inserted into the hub, through the micro catheter body and out the distal end with no resistance encountered.(phenom-27 2) the phenom-27 micro catheter total length was measured to be ~167.8cm and the usable length was measured to be ~161.2cm.As the model and lot numbers were not reported, compatibility to specification could not be confirmed.The micro catheter was flushed, and liquid blood and water exit the distal end.A 0.0265¿ mandrel was inserted into the hub, through the micro catheter body and out the distal end with no resistance encountered.Conclusion: based on the analysis findings, the customer report of ¿failure/incomplete open distal (flex)¿ could not be confirmed for both devices as both braids were returned fully opened.Possible causes of this failure during procedure are damage to pushwire, frayed ends on braid, patient vessel tortuosity, user does not maintain continuous flush, or user pulls back on/torques wire while advancing ped in micro catheter.The returned braid was found damaged/frayed; however, the cause could not be determined.Possible causes for damage are resheathing more than 2 times, high force delivery, over-manipulation, delivering/retracting delivery wire against resistance, deploying/resheathing braid against resistance, or damage during return shipping as the braid was returned without its protective dispenser coil or introducer sheath.Customer reported pipeline was resheathed more than 2 times, the pipeline was not placed within a bend, vessel tortuosity as normal and devices were prepared per ifu.No damages or irregularities were found with the returned micro catheters that would contribute towards the failure.One micro catheter had external scratches on the hub, which would not affect the deployment of the braid.As the two pipeline flex w/ shield pushers used during the event were not returned, any contribution of the pipeline flex w/ shield pushers towards the failure to open distal could not be determined.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 W/SHIELD TECHNOLOGY
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13485953
• Report Number: 2029214-2022-00179
• Device Sequence Number: 17489711
• Product Code: OUT
• UDI-Device Identifier: 00763000284619
• UDI-Public: 00763000284619
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2022

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: 09/24/2024
• Device Model Number: PED2-475-16
• Device Catalogue Number: PED2-475-16
• Device Lot Number: B271888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Sex: Female