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

Model Number	PED-425-18
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
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 due to severe tortuosity, the device did not open in the proximal curve of the aneurysm.It was noted the proximal part of the stent was positioned in a bend, more than 50% of the stent had been deployed, re-sheathing was done less than three times, and no additional steps were taken in an attempt to open the device.The microcatheter and pipeline were removed together, and replacement products were used to complete the procedure.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 looked good with second device.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the posterior communicating (pcom) artery sup raclinoid segment with a max diameter of 6 mm and a 4 mm neck diameter.It was noted the patient's  vessel tortuosity was severe.Dual antiplatelet therapy (dapt) was administered, but the platelet reactivity units (pru) level was unknown.Ancillary devices include a neuron max sheath, navien 5f guide catheter, phenom 27 microcatheter, avigo guidewire.
Additional Manufacturer Narrative
H3: the pipeline flex embolization device was returned still within the phenom 27 catheter.The pipeline flex pusher was extending from within the phenom 27 catheter hub for 46.8cm.The distal 3.5cm of the phenom 27 catheter body was found ¿wavy.¿ the pipeline flex tip coil was extending out from within the phenom 27 catheter distal tip.The pipeline flex tip coil was found damaged and bent.The pipeline flex embolization device was pushed out from within the phenom 27 catheter, deploying the braid.No bends or kinks were found with the pipeline flex pusher.However, the pusher was found detached at the distal hypotube weld (solder joint).There was no evidence of stretching or elongation with the pipeline flex pusher.The pipeline flex braid proximal and distal ends were found open but damaged (frayed).Dried blood was noted on the pusher ptfe sleeves.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: 11957673
• Report Number: 2029214-2021-00693
• Device Sequence Number: 3648284
• Product Code: OUT
• UDI-Device Identifier: 00847536016170
• UDI-Public: 00847536016170
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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: 10/29/2021
• Device Model Number: PED-425-18
• Device Catalogue Number: PED-425-18
• Device Lot Number: A731984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 52