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

Model Number	PED-500-16
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 report that the pipeline failed to open at the distal section.Device fell back into ica, physician attempted to open device at the point of the distal landing zone.Device would not open to diameter.Physician made maximum attempts at resheathing.Device appeared to be frayed on the angiogram.Device was removed from patient and a new pipeline was used with no problems.The devices were prepared and used per the instructions for use.The device was deployed less than 50% when it failed to open.The device was resheathed less than or equal to 2 times.No additional steps were made to open the device.This event occurred during the treatment of left pcom, unruptured, saccular aneurysms.The max diameter and neck were both 5mm.The distal landing zone was 4.17mm and the proximal was 4.98mm.The vessel anatomy was normal in tortuosity.
Additional Manufacturer Narrative
The pipeline flex embolization device was returned.The pipeline flex braid was returned detached from the pushwire.The pipeline flex embolization device was decontaminated.The distal hypotube and ptfe shrink tubing was found to be intact with no signs of elongation.No defects were found with the proximal bumper, re-sheathing pad, re-sheathing marker, distal marker, or tip coil.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The pipeline flex braid ends were found damaged (frayed); however, both ends of the braid were found open.Since the pipeline flex braid was returned detached from the pushwire, the distal and proximal ends of the braid were unable to be identified.No other anomalies were observed.Based on the device analysis and reported information, the reports of ¿failure/incomplete open¿ and ¿movement during deployment¿ could not be confirmed.It is possible that the braid damage contributed to the events.Patient vessel tortuosity, braid overstretching during delivery, or braid deployed in vessel bend can contribute to ¿failure/incomplete open¿ issue.In addition, vasospasm, patient vessel tortuosity, high force delivery, catheter kickback, or insufficient distal anchoring of braid can contribute to ¿movement during deployment¿ issue.However, the root causes 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
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9511514
• Report Number: 2029214-2019-01290
• Device Sequence Number: 2695123
• Product Code: OUT
• UDI-Device Identifier: 00836462015647
• UDI-Public: 00836462015647
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020

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: 08/05/2021
• Device Model Number: PED-500-16
• Device Catalogue Number: PED-500-16
• Device Lot Number: A687317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR