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

Model Number	PED-275-18
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2020
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 information regarding a pipeline guidewire that broke during a procedure.The patient was being treated for an unruptured saccular aneurysm of a communicating artery segment between the middle cerebral artery and ophthalmic artery.The aneurysm max diameter was 14mm and neck diameter was 6mm.Vessel tortuosity was severe.It was reported that the devices were prepared as indicated in the manufacturer instructions for use.There was some mild resistance of navigation throughout the procedure related to the patient's vessel tortuosity but was able to reach the correct location.After the pipeline was released, the surgeon pushed the marksman catheter up again to deliver the pipeline and remove the pushwire.When the pushwire was pulled back into the catheter, the surgeon found that it had broken at the hypotube proximal to the wire weld.Pump suctions was applied to the catheter and the whole system was removed from the patient to avoid any fragments of the fractured wire from being left in the patient's vessel.The patient did not sustain any harm or injury during the procedure.
Additional Manufacturer Narrative
Image review: based on the customer's images, the pushwire appeared to be separated at the hypotube proximal to the wire weld.The root cause 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: 10009249
• Report Number: 2029214-2020-00406
• Device Sequence Number: 2793839
• Product Code: OUT
• UDI-Device Identifier: 00847536014640
• UDI-Public: 00847536014640
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2020

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: 09/12/2022
• Device Model Number: PED-275-18
• Device Catalogue Number: PED-275-18
• Device Lot Number: A897378
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2020
• Supplement Date Received by Manufacturer: 04/25/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR