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

Model Number	PED-475-20
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2021
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 a report that the a pipeline failed to open in the distal end and the middle.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the right cavernous segment of the ica.The max diameter was 12mm, the neck diameter was 8.6mm, and the depth was 11mm.The patient's vessel tortuosity was severe.The landing zone was 3.8mm distal and 4.8mm proximal. dual antiplatelet treatment was administered, and the pru level was within the range deemed appropriate by the doctor.It was reported that the pipeline opened in a "fish mouth" manner distal, and continued deploying with good opening for 1-2mm.The device would then not open despite multiple re-sheaths and increasing and decreasing load in the system.It was decided to remove the pipeline since it was only open for a few mms distal and even that section did not appear right.More than 50% of the device had been deployed when the pipeline failed to open.The pipeline had been resheathed more than two times.No additional steps or other devices were taken to open the pipeline.The patient did not experience any injury or complications.Angiographic results post procedure showed all vessels were patent.The devices were prepared according to the instructions for use (ifu).
Additional Manufacturer Narrative
H3: based on the device analysis and reported information, the customer¿s report of ¿failure/incomplete open distal¿ was unable to be confirmed as each braid end of the pipeline flex braid were found to be open.Possible factors for failure to open is the result of vessel tortuosity or re-sheathing the device more than the recommended two times.The customer reported vessel anatomy was severe in tortuosity and re-sheathing the device more than the recommended two times.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
• 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: 12334409
• Report Number: 2029214-2021-01026
• Device Sequence Number: 4441683
• Product Code: OUT
• UDI-Device Identifier: 00847536016743
• UDI-Public: 00847536016743
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 11/14/2021

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: 07/17/2023
• Device Model Number: PED-475-20
• Device Catalogue Number: PED-475-20
• Device Lot Number: B055665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 11/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2020
• 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: 52 YR
• Patient Sex: Female