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

Model Number	PED-400-20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.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 the pipeline flex device' pushwire broke.The patient underwent embolization treatment for a unruptured amorphous supraclinoid internal carotid artery (ica), measuring 6mmx4mm, landing zone distal 3.5mm proximal 3.7mm.The vessel was observed normal tortuous.It was reported that catheter was flushed and prepared as per instructions for use (ifu).It was delivered to the desired location without any trouble.Ped-400-20 (ped) was advanced into the microcatheter.It was pushed well without any resistance, it was then attempted to be deploying but the operator was not happy with the opening hence tried to resheathed it with the microcatheter.Resistance was felt and all of a sudden pipeline pusher wire was moving freely into the catheter.The complete system was taken out to inspect.It was found that the distal portion of ped was broken and the catheter distal part was stretched.No patient symptoms or complications were associated with this event.Dual antiplatelet treatment was administered.Pru level was 157.The catheter was flushed as indicated per the ifu.The post procedure angiography results show successful deployment of another ped.
Additional Manufacturer Narrative
The pipeline flex and catheter were returned.No bends or kinks were found with the pushwire.The distal hypotube was found to be stretched and the ptfe pulled back.The dps sleeves were found to be intact.The proximal bumper, re-sheathing marker and re-sheathing pad were found to be intact.The pushwire was found to be broken proximal to braid.The proximal end of the pipeline flex braid was found to be collapsed.The distal end of pipeline flex braid was found fully collapsed.The proximal end of braid was found to be frayed.The tip coil was found to be intact and not damaged.No other damages or anomalies were found with the device.The broken end of the pushwire was sent out for sem analysis.Per the sem analysis report, features observed indicate a combination of tensile and torsional overload failure mechanisms.Based on the analysis findings,the returned pipeline flex braid damages are indicative of high force used.It is likely the damage occurred when the attempted to advance the pipeline flex through the catheter against the reported resistance.Possible contributors for resistance are patient vessel tortuosity or lack of continuous flush during delivery.Based on the device analysis and reported information, the report of ¿pushwire break/separation¿ was confirmed.Based on the investigation conducted, pushwire separation occurred due to a combination of tensile and torsional overload.The reported events can occur due to use of incompatible catheter, vessel tortuosity, failure to maintain continuous flush.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.The system is designed to allow for 2 full cycles of re-sheathing of the pipeline flex embolization device.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
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9450654
• Report Number: 2029214-2019-01217
• Device Sequence Number: 11532717
• Product Code: OUT
• UDI-Device Identifier: 00847536015937
• UDI-Public: 00847536015937
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2020

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: 10/16/2021
• Device Model Number: PED-400-20
• Device Catalogue Number: PED-400-20
• Device Lot Number: A725130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 02/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR