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

Model Number	PED2-450-14
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the pipeline failed to open distally.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the ica.The max diameter was 8mm, and the neck diameter was 6mm.The patient's vessel tortuosity was severe.The landing zone was 4.5mm distal and 4.7mm proximal. dual antiplatelet treatment was administered, and the pru level was 100.  it was reported that while attempting to deploy the pipeline, the distal segment would not open properly.The device was resheathed 2 times, and it did not look right and had a "tulip" look to it.The doctor removed the pipeline and opened it on the table and it was crimped at the distal end.The distal part of the pipeline was positioned in a bend when it failed to open, and less than 50% had been deployed.No additional steps had been taken to open the device. the pipeline was replaced, and the patient did not experience any injury or complications.Angiographic results post procedure were said to be great.The devices were prepared according to the instructions for use (ifu).
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Product analysis: equipment used: video inspection system (m-78210), ruler (m-83361), camera (panasonic lumix dmc-zs5) as found condition: the pipeline flex w/ shield braid was returned for analysis within a shipping box; within a resealable plastic pouch; within a sealed tyvek biohazard pouch; within a sealed plastic biohazard pouch; within an opened pipeline flex w/ shield inner pouch and within another resealable plastic biohazard pouch.The pipeline flex w/ shield pusher and unknown micro catheter used during the event was not returned for analysis.Visual inspection/damage location details: both ends of the braid were found tapered, frayed, and damaged.The middle braid was found damaged and damaged.No other anomalies were observed conclusion: based on the analysis findings, the customer report of ¿failure/incomplete open distal (flex)¿ and ¿pipeline damaged during delivery/retrieval¿ were confirmed.Possible causes are patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid overstretched during delivery, user deploys braid in vessel bend, or inappropriate anatomy.The returned braid was found damaged/frayed/flattened.Possible causes for damage are resheathing more than 2 times, high force delivery, over-manipulation, del ivering/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 2 times, the pipeline was placed within a bend, patient vessel tortuosity as severe and devices were prepared per ifu.As the pipeline flex w/ shield pusher and unknown micro catheter used during the event was not returned, any contribution of the pipeline flex w/ shield pusher and micro catheter towards the failure to open and pipeline damage could not be determined.As the model and lot numbers of the micro catheter were not reported, compatibility could not be assessed.There is no indication that the event is related to a potential manufacturing issue.H6.Coding updated based on analysis results.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: 13418984
• Report Number: 2029214-2022-00133
• Device Sequence Number: 4690791
• Product Code: OUT
• UDI-Device Identifier: 00763000284510
• UDI-Public: 00763000284510
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/04/2022

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: 12/02/2024
• Device Model Number: PED2-450-14
• Device Catalogue Number: PED2-450-14
• Device Lot Number: B306828
• 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: 01/26/2022
• Supplement Date Received by Manufacturer: 03/19/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2021
• 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 Sex: Female