MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; LASER THERAPY PRODUCT

Model Number	PED-475-12
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/09/2020
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 distal segment of the pipeline would not open.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the left paraopthalmic segment of the internal carotid artery with a max diameter of 13mm and a 5.5mm neck diameter.It was noted the patient's vessel tortuosity was severe.It was reported that the proximal segment of the pipeline opened as expected, however the distal segment under the ptfe sleeves would not open in the artery.The pipeline was re-sheathed less than three times, less than 50% of the device was deployed, and the middle segment of the device was in bend.No additional steps were taken to open the pipeline.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Post-procedure angiographic results were satisfactory with another therapy chosen.Ancillary devices include a 6f shuttle sheath, navien 072, and phenom 27.
Additional Manufacturer Narrative
The pipeline flex braid ends were found damaged (frayed); however, both ends of the braid were found open.As the pipeline flex braid was returned detached from the pushwire, the distal and proximal ends of the braid were unable to be identified.The distal hypotube and ptfe shrink tubing was intact.However, the shrink tubing was pulled back from the proximal bumper.No defects were found with the proximal bumper, re-sheathing pad, or re-sheathing marker.The ptfe sleeves with restraints were found in good condition.The tip coil was found bent.No other anomalies were observed.There was no indication that the event was related to a potential manufacturing issue.Based on the device analysis and reported information, the customer¿s report of ¿failure/incomplete open¿ could not be confirmed based on device evaluation, as the device has been fully deployed and re-sheathed.In this event it is likely the patient¿s ¿severe¿ vessel tortuosity contributed to the event.In addition, it was reported the braid was deployed in a vessel bend.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: LASER THERAPY PRODUCT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10155207
• Report Number: 2029214-2020-00559
• Device Sequence Number: 13903173
• Product Code: OUT
• UDI-Device Identifier: 00847536016620
• UDI-Public: 00847536016620
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2020

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: 10/08/2022
• Device Model Number: PED-475-12
• Device Catalogue Number: PED-475-12
• Device Lot Number: A911801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 09/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1